Trial Outcomes & Findings for A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)-China Extension Study (NCT NCT03875092)

Last Updated: 2024-10-01

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as ≥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 ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented. Data are from the product-limit (Kaplan-Meier) method for censored data.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

125 participants

Primary outcome timeframe

Up to approximately 33 months

Results posted on

2024-10-01

Participant Flow

The China extension study included participants previously enrolled in China in the global study for MK-3475-407 (NCT02775435) plus those enrolled during the China extension enrollment period.

Participant milestones

Participant milestones
Measure	Pembrolizumab + Chemotherapy Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Overall Study STARTED	65	60
Overall Study Treated	65	60
Overall Study Switched to Pembrolizumab+Chemotherapy	0	38
Overall Study Received Second Course of Pembrolizumab	6	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	65	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab + Chemotherapy Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Overall Study Adverse Event	2	5
Overall Study Death	44	51
Overall Study Participation Was Terminated By Sponsor	19	4

Baseline Characteristics

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)-China Extension Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Total n=125 Participants Total of all reporting groups
Age, Continuous	61.6 Years STANDARD_DEVIATION 8.7 • n=5 Participants	61.5 Years STANDARD_DEVIATION 9.1 • n=7 Participants	61.5 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	57 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) TPS <1%	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) TPS ≥1%	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) Unknown	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Taxane Chemotherapy +Paclitaxel	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Taxane Chemotherapy +Nab-paclitaxel	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Geographic Region East Asia	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Geographic Region Non-East Asia	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 33 months

Population: The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	8.3 Months Interval 6.2 to 10.5	4.2 Months Interval 4.0 to 5.4

PRIMARY outcome

Timeframe: Up to approximately 39 months

OS was defined as the time from randomization to death due to any cause. OS is presented. Data are from the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Overall Survival (OS)	30.1 Months Interval 18.2 to NA=OS upper limit not reached	12.7 Months Interval 9.4 to 17.3

SECONDARY outcome

Timeframe: Up to approximately 33 months

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	80.0 Percentage of Participants Interval 68.2 to 88.9	43.3 Percentage of Participants Interval 30.6 to 56.8

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.

For participants who demonstrated a confirmed response (Complete Response \[CR\]: Disappearance of all target lesions or Partial Response \[PR\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death. DOR as assessed by blinded independent central review per RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	7.1 Months Interval 4.9 to 14.4	3.5 Months Interval 2.8 to 4.9

SECONDARY outcome

Timeframe: Up to approximately 31 months

Population: The Safety population consisted of all participants who received ≥1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented. Data are from the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Number of Participants Who Experienced an Adverse Event (AE)	65 Participants	60 Participants

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The Safety population consisted of all participants who received ≥1 dose of study treatment.

The number of participants who discontinued study treatment due to an AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy n=65 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 Participants Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	8 Participants	4 Participants

Adverse Events

Pembrolizumab + Chemotherapy

Serious events: 35 serious events

Other events: 65 other events

Deaths: 41 deaths

Chemotherapy

Serious events: 22 serious events

Other events: 60 other events

Deaths: 22 deaths

Chemotherapy > Pembrolizumab Switch Over

Serious events: 10 serious events

Other events: 32 other events

Deaths: 34 deaths

Pembrolizumab > Pembrolizumab Second Course

Serious events: 0 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Pembrolizumab + Chemotherapy n=65 participants at risk Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 participants at risk Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy > Pembrolizumab Switch Over n=38 participants at risk Eligible participants with documented disease progression following chemotherapy in "Chemotherapy" arm switched over to receive pembrolizumab 200 mg IV Q3W for up to 35 administrations (approximately 2 years).	Pembrolizumab > Pembrolizumab Second Course n=6 participants at risk Eligible participants who received pembrolizumab as a first course (200 mg IV Q3W for up to 35 administrations) and stopped the first course of pembrolizumab due to complete response; or completed the first course of pembrolizumab and had stable disease, partial response, or complete response; but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
Blood and lymphatic system disorders Febrile neutropenia	4.6% 3/65 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	4.6% 3/65 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	7.7% 5/65 • Number of events 6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	6.2% 4/65 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.3% 2/60 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Angina unstable	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Coronary artery disease	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Myocardial infarction	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hypothyroidism	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Colitis	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastritis	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chest pain	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Malaise	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.3% 2/60 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Bile duct stone	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Immune system disorders Anaphylactic shock	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Appendicitis	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	9.2% 6/65 • Number of events 8 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.3% 5/60 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.2% 5/38 • Number of events 6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia fungal	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pulmonary tuberculosis	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Upper respiratory tract infection	3.1% 2/65 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Alanine aminotransferase increased	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Neutrophil count decreased	3.1% 2/65 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Platelet count decreased	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Troponin T increased	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Diabetic ketoacidosis	3.1% 2/65 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	1.5% 1/65 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Type 1 diabetes mellitus	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebral haemorrhage	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebral infarction	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.

Other adverse events
Measure	Pembrolizumab + Chemotherapy n=65 participants at risk Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under the Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy n=60 participants at risk Participants received normal saline by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles PLUS paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Chemotherapy > Pembrolizumab Switch Over n=38 participants at risk Eligible participants with documented disease progression following chemotherapy in "Chemotherapy" arm switched over to receive pembrolizumab 200 mg IV Q3W for up to 35 administrations (approximately 2 years).	Pembrolizumab > Pembrolizumab Second Course n=6 participants at risk Eligible participants who received pembrolizumab as a first course (200 mg IV Q3W for up to 35 administrations) and stopped the first course of pembrolizumab due to complete response; or completed the first course of pembrolizumab and had stable disease, partial response, or complete response; but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
Blood and lymphatic system disorders Anaemia	64.6% 42/65 • Number of events 103 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	76.7% 46/60 • Number of events 85 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	28.9% 11/38 • Number of events 17 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	18.5% 12/65 • Number of events 49 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.7% 7/60 • Number of events 32 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	6.2% 4/65 • Number of events 6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.7% 4/60 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hyperthyroidism	18.5% 12/65 • Number of events 16 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hypothyroidism	12.3% 8/65 • Number of events 15 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain	6.2% 4/65 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Constipation	24.6% 16/65 • Number of events 20 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	23.3% 14/60 • Number of events 21 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	16.9% 11/65 • Number of events 23 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.0% 6/60 • Number of events 11 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	33.3% 2/6 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Nausea	36.9% 24/65 • Number of events 42 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	21.7% 13/60 • Number of events 22 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.3% 2/38 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	23.1% 15/65 • Number of events 26 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 10/60 • Number of events 12 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.3% 2/38 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	15.4% 10/65 • Number of events 16 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	11.7% 7/60 • Number of events 9 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chest discomfort	7.7% 5/65 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chest pain	6.2% 4/65 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.0% 9/60 • Number of events 10 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Fatigue	7.7% 5/65 • Number of events 13 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 8 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Inflammation	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Malaise	12.3% 8/65 • Number of events 9 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.3% 8/60 • Number of events 9 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	18.5% 12/65 • Number of events 14 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.0% 9/60 • Number of events 10 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hyperbilirubinaemia	6.2% 4/65 • Number of events 6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	10.8% 7/65 • Number of events 8 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.0% 6/60 • Number of events 7 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	10.5% 4/38 • Number of events 6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Upper respiratory tract infection	13.8% 9/65 • Number of events 12 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Urinary tract infection	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.3% 2/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Alanine aminotransferase increased	36.9% 24/65 • Number of events 40 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	28.3% 17/60 • Number of events 26 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	15.8% 6/38 • Number of events 7 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Aspartate aminotransferase increased	29.2% 19/65 • Number of events 33 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	21.7% 13/60 • Number of events 21 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Bilirubin conjugated increased	4.6% 3/65 • Number of events 18 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.7% 4/60 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood albumin decreased	6.2% 4/65 • Number of events 9 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	3.3% 2/60 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood alkaline phosphatase increased	10.8% 7/65 • Number of events 15 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.3% 2/38 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood bilirubin increased	7.7% 5/65 • Number of events 26 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.7% 4/60 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood chloride decreased	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood cholinesterase decreased	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood creatinine increased	6.2% 4/65 • Number of events 11 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	6.7% 4/60 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	7.9% 3/38 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	33.3% 2/6 • Number of events 5 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood lactate dehydrogenase increased	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood sodium decreased	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood urea increased	3.1% 2/65 • Number of events 4 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	1.7% 1/60 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.3% 2/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood uric acid increased	7.7% 5/65 • Number of events 16 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	5.0% 3/60 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Electrocardiogram QT prolonged	0.00% 0/65 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/60 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Gamma-glutamyltransferase increased	15.4% 10/65 • Number of events 12 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	18.3% 11/60 • Number of events 14 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	13.2% 5/38 • Number of events 7 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Neutrophil count decreased	76.9% 50/65 • Number of events 195 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	71.7% 43/60 • Number of events 128 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Neutrophil count increased	1.5% 1/65 • Number of events 1 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	8.3% 5/60 • Number of events 6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/38 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/6 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
Investigations Platelet count decreased	24.6% 16/65 • Number of events 53 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	36.7% 22/60 • Number of events 37 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	2.6% 1/38 • Number of events 3 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.	16.7% 1/6 • Number of events 2 • All-Cause mortality: Up to 1948 days Adverse events: Up to 1625 days Mortality data were collected for all randomized participants. Adverse event (AE) data were collected for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore Medical Dictionary for Regulatory Activities (MedDRA) terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.