Trial Outcomes & Findings for Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (NCT NCT04456699)

NCT ID: NCT04456699

Last Updated: 2024-10-29

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS using RECIST 1.1 as assessed by BICR is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 335 participants
• Primary outcome timeframe: Up to approximately 30 months
• Results posted on: 2024-10-29

Participant Flow

Eligible participants were randomized 1:1:1 to receive either Olaparib + Bevacizumab, Olaparib, or Bevacizumab + chemotherapy.

Participant milestones

Measure	Olaparib + Bevacizumab Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Overall Study STARTED	111	115	109
Overall Study Treated	111	113	108
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	111	115	109

Reasons for withdrawal

Measure	Olaparib + Bevacizumab Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Overall Study Death	48	50	52
Overall Study Physician Decision	0	0	2
Overall Study Sponsor Decision	55	61	50
Overall Study Withdrawal by Subject	8	4	5

Baseline Characteristics

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)

Baseline characteristics by cohort

Measure	Olaparib + Bevacizumab n=111 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=115 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=109 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.	Total n=335 Participants Total of all reporting groups
Response to Prior Induction CR/PR	49 Participants n=5 Participants	48 Participants n=7 Participants	47 Participants n=5 Participants	144 Participants n=4 Participants
Number of Induction Cycles >8 cycles for FOLFOX + bevacizumab or >6 cycles for CAPOX + bevacizumab	58 Participants n=5 Participants	58 Participants n=7 Participants	56 Participants n=5 Participants	172 Participants n=4 Participants
Mutation Status BRAF and RAS all wild type	32 Participants n=5 Participants	33 Participants n=7 Participants	29 Participants n=5 Participants	94 Participants n=4 Participants
Mutation Status BRAF or RAS Mutation	79 Participants n=5 Participants	82 Participants n=7 Participants	80 Participants n=5 Participants	241 Participants n=4 Participants
Age, Continuous	59.5 Years STANDARD_DEVIATION 12.8 • n=5 Participants	61.1 Years STANDARD_DEVIATION 10.7 • n=7 Participants	63.2 Years STANDARD_DEVIATION 11.3 • n=5 Participants	61.3 Years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	49 Participants n=7 Participants	44 Participants n=5 Participants	143 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	66 Participants n=7 Participants	65 Participants n=5 Participants	192 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	44 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	93 Participants n=7 Participants	94 Participants n=5 Participants	275 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	40 Participants n=7 Participants	30 Participants n=5 Participants	95 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	64 Participants n=7 Participants	66 Participants n=5 Participants	201 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Response to Prior Induction SD	62 Participants n=5 Participants	67 Participants n=7 Participants	62 Participants n=5 Participants	191 Participants n=4 Participants
Number of Induction Cycles 6-8 cycles for FOLFOX + bevacizumab or 4-6 cycles for CAPOX + bevacizumab	53 Participants n=5 Participants	57 Participants n=7 Participants	53 Participants n=5 Participants	163 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population included all randomized participants.

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per 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 demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS using RECIST 1.1 as assessed by BICR is presented.

Outcome measures

Measure	Olaparib + Bevacizumab n=111 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=115 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=109 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	3.7 Months Interval 3.4 to 5.3	3.6 Months Interval 2.0 to 3.7	5.5 Months Interval 3.8 to 5.6

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population consists of all randomized participants.

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

Outcome measures

Measure	Olaparib + Bevacizumab n=111 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=115 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=109 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Overall Survival (OS)	21.2 Months Interval 15.1 to NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	21.6 Months Interval 17.2 to NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	19.9 Months Interval 13.8 to 22.5

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: The analysis population consisted of all randomized participants who had a measurable disease.

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

Outcome measures

Measure	Olaparib + Bevacizumab n=104 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=107 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=105 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR	4.8 Percentage of Participants Interval 1.6 to 10.9	1.9 Percentage of Participants Interval 0.2 to 6.6	4.8 Percentage of Participants Interval 1.6 to 10.8

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: All randomized participants who received at least 1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced at least one AE was reported for each arm.

Outcome measures

Measure	Olaparib + Bevacizumab n=111 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=113 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=108 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Number of Participants With One or More Adverse Events (AE)	101 Participants	91 Participants	96 Participants

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: All randomized participants who received at least 1 dose of study treatment.

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

Outcome measures

Measure	Olaparib + Bevacizumab n=111 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=113 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=108 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Number of Participants Discontinuing Study Intervention Due to an AE	6 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: All randomized participants who received at least one dose of treatment and had either a CR or a PR.

For participants who demonstrate a confirmed 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 is defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions is also considered PD. DOR assessments will be based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experience a confirmed CR or PR will be presented.

Outcome measures

Measure	Olaparib + Bevacizumab n=5 Participants Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=2 Participants Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=5 Participants Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	NA Months Interval 3.6 to NA = Median and upper limit of 95% CI for DOR was not reached due to insufficient number of participants with a response.	NA Months NA = Median, lower limit, and upper limit of 95% CI for DOR was not reached due to insufficient number of participants with a response.	NA Months NA = Median, lower limit, and upper limit of 95% CI for DOR was not reached due to insufficient number of participants with a response.

Adverse Events

Olaparib + Bevacizumab

Serious events: 16 serious events

Other events: 94 other events

Deaths: 49 deaths

Olaparib

Serious events: 13 serious events

Other events: 74 other events

Deaths: 51 deaths

Bevacizumab + Chemotherapy

Serious events: 14 serious events

Other events: 86 other events

Deaths: 52 deaths

Serious adverse events

Measure	Olaparib + Bevacizumab n=111 participants at risk Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=113 participants at risk Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=108 participants at risk Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Acute coronary syndrome	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardiac failure	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Myocardial infarction	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Enteritis	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastric haemorrhage	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intestinal perforation	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Nausea	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.8% 2/113 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Rectal perforation	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Small intestinal perforation	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Stomatitis	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.9% 2/108 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Biliary tract infection	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations COVID-19	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Cellulitis	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Escherichia sepsis	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Large intestine infection	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Parotitis	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Peritonitis	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Peritonsillar abscess	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Sepsis	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Septic shock	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Skin candida	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Urinary tract infection	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Human rhinovirus test positive	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Neutrophil count decreased	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations White blood cell count decreased	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Dehydration	0.90% 1/111 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Ischaemic stroke	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Seizure	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Peripheral artery thrombosis	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/108 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.

Other adverse events

Measure	Olaparib + Bevacizumab n=111 participants at risk Participants received olaparib (300 mg twice daily \[BID\] oral) + Bevacizumab (5 mg/kg intravenous \[IV\] once every 2 weeks \[Q2W\]) until progressive disease or end of study.	Olaparib n=113 participants at risk Participants received olaparib (300 mg BID) oral, until progressive disease or end of study.	Bevacizumab + Chemotherapy n=108 participants at risk Participants received investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m\^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) was added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) Q2W IV infusion was added per investigator's discretion. Treatment continued until progressive disease or end of study.
Blood and lymphatic system disorders Anaemia	28.8% 32/111 • Number of events 35 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	18.6% 21/113 • Number of events 25 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.4% 8/108 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	8.1% 9/111 • Number of events 14 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.4% 5/113 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.93% 1/108 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	6.3% 7/111 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.9% 2/108 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain	17.1% 19/111 • Number of events 22 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.1% 8/113 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.0% 13/108 • Number of events 14 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	7.2% 8/111 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.5% 4/113 • Number of events 5 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.9% 2/108 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Constipation	14.4% 16/111 • Number of events 18 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.7% 11/113 • Number of events 11 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.0% 14/108 • Number of events 15 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	9.9% 11/111 • Number of events 16 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.0% 9/113 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.9% 15/108 • Number of events 15 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Nausea	27.9% 31/111 • Number of events 38 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	20.4% 23/113 • Number of events 26 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 24/108 • Number of events 35 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Stomatitis	7.2% 8/111 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.5% 4/113 • Number of events 4 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.2% 11/108 • Number of events 13 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	11.7% 13/111 • Number of events 17 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.2% 7/113 • Number of events 13 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.2% 11/108 • Number of events 14 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	14.4% 16/111 • Number of events 22 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.1% 8/113 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.2% 11/108 • Number of events 14 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Fatigue	12.6% 14/111 • Number of events 15 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.3% 15/113 • Number of events 15 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.3% 10/108 • Number of events 11 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	9.0% 10/111 • Number of events 10 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.4% 5/113 • Number of events 5 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.5% 7/108 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Urinary tract infection	4.5% 5/111 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.5% 4/113 • Number of events 4 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.6% 6/108 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Aspartate aminotransferase increased	4.5% 5/111 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.3% 6/113 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.6% 6/108 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood creatinine increased	3.6% 4/111 • Number of events 4 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.8% 2/113 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.6% 6/108 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Neutrophil count decreased	8.1% 9/111 • Number of events 20 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.2% 7/113 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.8% 3/108 • Number of events 5 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Platelet count decreased	1.8% 2/111 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.3% 6/113 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.5% 7/108 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Weight decreased	6.3% 7/111 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.8% 2/113 • Number of events 2 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.6% 6/108 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	13.5% 15/111 • Number of events 15 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	15.9% 18/113 • Number of events 20 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 12/108 • Number of events 13 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/111 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.3% 10/108 • Number of events 12 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 9/111 • Number of events 13 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.2% 7/113 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.4% 8/108 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	7.2% 8/111 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 3/113 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.4% 8/108 • Number of events 9 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.4% 6/111 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.6% 5/108 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Dysgeusia	9.0% 10/111 • Number of events 12 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 3/113 • Number of events 4 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.8% 3/108 • Number of events 4 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Headache	6.3% 7/111 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.88% 1/113 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.8% 3/108 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Neuropathy peripheral	2.7% 3/111 • Number of events 5 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.2% 7/113 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.7% 4/108 • Number of events 4 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Proteinuria	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 3/113 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.3% 10/108 • Number of events 13 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	5.4% 6/111 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 3/113 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.8% 3/108 • Number of events 3 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.4% 6/111 • Number of events 7 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.7% 4/108 • Number of events 6 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.90% 1/111 • Number of events 1 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.4% 8/108 • Number of events 8 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypertension	9.9% 11/111 • Number of events 12 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/113 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.3% 10/108 • Number of events 13 • Up to approximately 38 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER