Trial Outcomes & Findings for First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590) (NCT NCT03189719)

NCT ID: NCT03189719

Last Updated: 2024-10-15

Results Overview

Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the Intent-To-Treat (ITT) population (all randomized) who had ESCC and who were PD-L1 CPS ≥10.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 749 participants
• Primary outcome timeframe: Up to approximately 34 months
• Results posted on: 2024-10-15

Participant Flow

749 participants were randomized 1:1 to receive either pembrolizumab plus standard of care (SOC) chemotherapy, or placebo plus SOC chemotherapy.

Participant milestones

Measure	Pembrolizumab + SOC Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-fluorouracil (5-FU) 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Overall Study STARTED	373	376
Overall Study Treated	370	370
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	373	376

Reasons for withdrawal

Measure	Pembrolizumab + SOC Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-fluorouracil (5-FU) 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Overall Study Death	325	361
Overall Study Physician Decision	1	0
Overall Study Sponsor Decision	40	12
Overall Study Withdrawal by Subject	7	3

Baseline Characteristics

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

Baseline characteristics by cohort

Measure	Pembrolizumab + SOC n=373 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=376 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Total n=749 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	315 Participants n=5 Participants	296 Participants n=7 Participants	611 Participants n=5 Participants
Age, Continuous	62.8 Years STANDARD_DEVIATION 9.8 • n=5 Participants	62.0 Years STANDARD_DEVIATION 9.2 • n=7 Participants	62.4 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	57 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	306 Participants n=5 Participants	319 Participants n=7 Participants	625 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	57 Participants n=7 Participants	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Asian	201 Participants n=5 Participants	199 Participants n=7 Participants	400 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	139 Participants n=5 Participants	139 Participants n=7 Participants	278 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Geographic Region Asia	196 Participants n=5 Participants	197 Participants n=7 Participants	393 Participants n=5 Participants
Geographic Region Rest of World	177 Participants n=5 Participants	179 Participants n=7 Participants	356 Participants n=5 Participants
Histology Adenocarcinoma	99 Participants n=5 Participants	102 Participants n=7 Participants	201 Participants n=5 Participants
Histology Squamous Cell Carcinoma	274 Participants n=5 Participants	274 Participants n=7 Participants	548 Participants n=5 Participants
Eastern Cooperative Group Performance Status (ECOG PS) ECOG PS 0	149 Participants n=5 Participants	150 Participants n=7 Participants	299 Participants n=5 Participants
Eastern Cooperative Group Performance Status (ECOG PS) ECOG PS 1	223 Participants n=5 Participants	225 Participants n=7 Participants	448 Participants n=5 Participants
Eastern Cooperative Group Performance Status (ECOG PS) ECOG PS 2	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed.

Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the Intent-To-Treat (ITT) population (all randomized) who had ESCC and who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=143 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=143 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)	13.9 Months Interval 11.1 to 17.7	8.8 Months Interval 7.8 to 10.5

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC were analyzed.

Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who had ESCC.

Outcome measures

Measure	Pembrolizumab + SOC n=274 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=274 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
OS in Participants With ESCC	12.6 Months Interval 10.2 to 14.3	9.8 Months Interval 8.6 to 11.1

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.

Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=186 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=197 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	13.5 Months Interval 11.1 to 15.6	9.4 Months Interval 8.0 to 10.7

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) were analyzed.

Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized).

Outcome measures

Measure	Pembrolizumab + SOC n=373 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=376 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
OS in All Participants	12.4 Months Interval 10.5 to 14.0	9.8 Months Interval 8.8 to 10.8

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC were analyzed.

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who had ESCC.

Outcome measures

Measure	Pembrolizumab + SOC n=274 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=274 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC	6.3 Months Interval 6.2 to 6.9	5.8 Months Interval 5.0 to 6.1

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=186 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=197 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	7.5 Months Interval 6.2 to 8.2	5.5 Months Interval 4.3 to 6.0

PRIMARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) were analyzed.

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred 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 had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized).

Outcome measures

Measure	Pembrolizumab + SOC n=373 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=376 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
PFS Per RECIST 1.1 As Assessed By Investigator in All Participants	6.3 Months Interval 6.2 to 6.9	5.8 Months Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) were analyzed.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized).

Outcome measures

Measure	Pembrolizumab + SOC n=373 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=376 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants	45.0 Percentage of Participants Interval 39.9 to 50.2	29.3 Percentage of Participants Interval 24.7 to 34.1

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC and who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=143 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=143 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	51.0 Percentage of Participants Interval 42.6 to 59.5	28.0 Percentage of Participants Interval 20.8 to 36.1

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC were analyzed.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC.

Outcome measures

Measure	Pembrolizumab + SOC n=274 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=274 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC	43.8 Percentage of Participants Interval 37.8 to 49.9	31.0 Percentage of Participants Interval 25.6 to 36.9

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=186 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=197 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	51.1 Percentage of Participants Interval 43.7 to 58.5	26.9 Percentage of Participants Interval 20.8 to 33.7

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) who demonstrated a confirmed CR or PR were analyzed.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR.

Outcome measures

Measure	Pembrolizumab + SOC n=168 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=110 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants	8.3 Months Interval 6.4 to 10.4	6.0 Months Interval 4.4 to 6.4

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 who demonstrated a confirmed CR or PR were analyzed were analyzed.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC and were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=73 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=40 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	10.4 Months Interval 8.0 to 16.2	4.4 Months Interval 4.1 to 6.2

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) with ESCC who demonstrated a confirmed CR or PR were analyzed.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC.

Outcome measures

Measure	Pembrolizumab + SOC n=120 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=85 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC	9.1 Months Interval 6.6 to 12.3	6.1 Months Interval 4.4 to 6.4

SECONDARY outcome

Timeframe: Up to approximately 34 months

Population: All randomized participants (ITT population) who were PD-L1 CPS ≥10 and who demonstrated a confirmed CR or PR were analyzed.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=95 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=53 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	10.4 Months Interval 6.7 to 14.5	5.6 Months Interval 4.3 to 6.5

SECONDARY outcome

Timeframe: Up to approximately 28 months

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

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.

Outcome measures

Measure	Pembrolizumab + SOC n=370 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=370 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Number of Participants With an Adverse Event (AE)	370 Participants	368 Participants

SECONDARY outcome

Timeframe: Up to approximately 27 months

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

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that discontinued any study drug due to an AE was reported for each treatment arm.

Outcome measures

Measure	Pembrolizumab + SOC n=370 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=370 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Number of Participants Discontinuing Study Treatment Due to an AE	90 Participants	74 Participants

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC-QLQ-C30 assessment were analyzed.

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants.

Outcome measures

Measure	Pembrolizumab + SOC n=366 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=363 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants	-1.74 Score on a Scale Interval -4.24 to 0.75	-1.64 Score on a Scale Interval -4.21 to 0.92

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, who had ESCC, and who were PD-L1 CPS ≥10 were analyzed.

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC and who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=142 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=138 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	-2.36 Score on a Scale Interval -6.58 to 1.87	-0.40 Score on a Scale Interval -4.86 to 4.05

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, and who had ESCC were analyzed.

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC.

Outcome measures

Measure	Pembrolizumab + SOC n=270 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=264 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC	-2.00 Score on a Scale Interval -4.9 to 0.89	-1.94 Score on a Scale Interval -4.93 to 1.06

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, and who were PD-L1 CPS ≥10 were analyzed.

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who were PD-L1 CPS ≥10.

Outcome measures

Measure	Pembrolizumab + SOC n=184 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=191 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	-1.73 Score on a Scale Interval -5.5 to 2.04	0.04 Score on a Scale Interval -3.77 to 3.85

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC QLQ-OES18 assessment were analyzed.

The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Pembrolizumab + SOC n=366 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=359 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants Dysphagia subscale	-3.18 Score on a Scale Interval -7.19 to 0.82	2.36 Score on a Scale Interval -1.77 to 6.49
Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants Pain subscale	-4.78 Score on a Scale Interval -7.01 to -2.56	-1.85 Score on a Scale Interval -4.14 to 0.45
Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants Reflux subscale	-0.22 Score on a Scale Interval -2.81 to 2.36	0.71 Score on a Scale Interval -1.96 to 3.38

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC QLQ-OES18 assessment, and with ESCC and PD-L1 CPS ≥10 were analyzed.

The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC who were PD-L1 CPS≥10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Pembrolizumab + SOC n=142 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=135 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) Dysphagia subscale	-5.11 Score on a Scale Interval -11.51 to 1.3	3.57 Score on a Scale Interval -3.22 to 10.36
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) Pain subscale	-2.55 Score on a Scale Interval -6.11 to 1.01	-0.42 Score on a Scale Interval -4.2 to 3.36
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) Reflux subscale	-0.16 Score on a Scale Interval -4.43 to 4.11	4.94 Score on a Scale Interval 0.43 to 9.46

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC QLQ-OES18 assessment, and with ESCC were analyzed.

The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Pembrolizumab + SOC n=270 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=261 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Dysphagia subscale	-1.18 Score on a Scale Interval -5.82 to 3.47	3.32 Score on a Scale Interval -1.5 to 8.13
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Pain subscale	-4.03 Score on a Scale Interval -6.64 to -1.43	-2.33 Score on a Scale Interval -5.02 to 0.37
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Reflux subscale	-0.40 Score on a Scale Interval -3.39 to 2.59	1.09 Score on a Scale Interval -2.01 to 4.19

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC QLQ-OES18 assessment, and with PD-L1 CPS ≥10 were analyzed.

The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants who were PD-L1 CPS≥10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Pembrolizumab + SOC n=184 Participants Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=187 Participants Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) Dysphagia subscale	-7.18 Score on a Scale Interval -12.76 to -1.6	1.02 Score on a Scale Interval -4.66 to 6.7
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) Pain subscale	-3.51 Score on a Scale Interval -6.69 to -0.33	0.07 Score on a Scale Interval -3.18 to 3.31
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) Reflux subscale	-0.52 Score on a Scale Interval -4.17 to 3.14	4.25 Score on a Scale Interval 0.52 to 7.97

Adverse Events

Pembrolizumab + SOC

Serious events: 207 serious events

Other events: 367 other events

Deaths: 331 deaths

Placebo + SOC

Serious events: 204 serious events

Other events: 364 other events

Deaths: 363 deaths

Serious adverse events

Measure	Pembrolizumab + SOC n=370 participants at risk Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=370 participants at risk Participants received placebo to pembrolizumab (saline) IV Q3W along with SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Vascular disorders Aortic thrombosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Deep vein thrombosis	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Dry gangrene	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Hypotension	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Jugular vein thrombosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Orthostatic hypotension	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Peripheral ischaemia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Subclavian vein thrombosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Thrombosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Vena cava thrombosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Venous thrombosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Anaemia	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.7% 10/370 • Number of events 10 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 9/370 • Number of events 9 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.5% 13/370 • Number of events 13 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Leukopenia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Neutropenia	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Acute coronary syndrome	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Acute myocardial infarction	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Angina unstable	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Arteriospasm coronary	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Atrial fibrillation	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Atrial flutter	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Bradycardia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardiac arrest	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardiac failure	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Cardio-respiratory arrest	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Coronary artery stenosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Myocardial infarction	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Palpitations	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Pericardial effusion	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Pericarditis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Cardiac disorders Supraventricular tachycardia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Adrenal insufficiency	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Graves' disease	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hyperthyroidism	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hypophysitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hypopituitarism	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Ascites	0.27% 1/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Autoimmune colitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Colitis	1.1% 4/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Constipation	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Diaphragmatic hernia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Diarrhoea	1.9% 7/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Duodenal perforation	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Duodenitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Dyspepsia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Dysphagia	4.6% 17/370 • Number of events 20 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.5% 13/370 • Number of events 13 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Enteritis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Enterocolitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Faecaloma	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastric fistula	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastric haemorrhage	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastric ulcer	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.1% 4/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Haematemesis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Haemorrhoids	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Ileus	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Inguinal hernia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Nausea	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.9% 7/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Oesophageal fistula	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Oesophageal obstruction	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Oesophageal stenosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Pancreatitis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Stomatitis	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Vomiting	2.4% 9/370 • Number of events 11 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Asthenia	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Chest discomfort	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Chest pain	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Death	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.9% 7/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Fatigue	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders General physical health deterioration	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Malaise	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Mucosal inflammation	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Multiple organ dysfunction syndrome	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Pain	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Pneumatosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Pyrexia	1.4% 5/370 • Number of events 8 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Strangulated hernia	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Sudden cardiac death	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Systemic inflammatory response syndrome	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Vascular device occlusion	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Autoimmune hepatitis	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Bile duct stone	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Biliary obstruction	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Cholangitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Granulomatous liver disease	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Hepatic failure	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Hepatic function abnormal	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Hepatitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Hepatobiliary disorders Liver disorder	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Immune system disorders Hypersensitivity	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Abdominal infection	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Abdominal wall infection	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Abscess	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Acute sinusitis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Anal abscess	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Bacteraemia	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Bronchitis	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations COVID-19	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Clostridium difficile colitis	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Cytomegalovirus infection	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Device related infection	0.81% 3/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Device related sepsis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Diverticulitis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Extradural abscess	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Giardiasis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Infection	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Influenza	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Intervertebral discitis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Large intestine infection	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Oral candidiasis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumocystis jirovecii pneumonia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia	10.3% 38/370 • Number of events 40 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.6% 32/370 • Number of events 36 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia aspiration	3.0% 11/370 • Number of events 11 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.9% 7/370 • Number of events 8 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia influenzal	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Psoas abscess	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pulmonary sepsis	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pulmonary tuberculosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pyelonephritis acute	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Respiratory tract infection	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Salmonellosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Sepsis	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Septic shock	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Skin infection	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Stoma site infection	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Systemic candida	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Urinary tract infection	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Vascular device infection	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Viral myositis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Accidental overdose	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Anastomotic fistula	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Fall	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Gastrointestinal anastomotic stenosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Hip fracture	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Post procedural complication	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Product administration error	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Injury, poisoning and procedural complications Wound dehiscence	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Alanine aminotransferase increased	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Aspartate aminotransferase increased	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Blood creatinine increased	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Neutrophil count decreased	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Platelet count decreased	1.4% 5/370 • Number of events 5 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.7% 10/370 • Number of events 13 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations White blood cell count decreased	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.1% 4/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Cachexia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Dehydration	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.2% 8/370 • Number of events 9 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyperammonaemia	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypocalcaemia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypochloraemia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypoglycaemia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	1.9% 7/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypomagnesaemia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	1.9% 7/370 • Number of events 8 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypophagia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Malnutrition	0.54% 2/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Muscle twitching	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal submucosal tumour	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm swelling	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cerebral haemorrhage	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cerebral infarction	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cerebral ischaemia	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Cognitive disorder	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Depressed level of consciousness	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Encephalopathy	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Epilepsy	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Ischaemic stroke	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Loss of consciousness	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Seizure	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Subarachnoid haemorrhage	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Syncope	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Transient ischaemic attack	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Vocal cord paralysis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Product Issues Device dislocation	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Product Issues Device failure	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Product Issues Device occlusion	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Confusional state	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Personality change	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Acute kidney injury	3.0% 11/370 • Number of events 12 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.6% 6/370 • Number of events 6 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Chronic kidney disease	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Prerenal failure	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Proteinuria	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Renal failure	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Renal impairment	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Renal injury	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Ureteric obstruction	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Emphysema	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oesophagobronchial fistula	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.81% 3/370 • Number of events 3 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 12/370 • Number of events 13 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.9% 7/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	1.9% 7/370 • Number of events 7 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.54% 2/370 • Number of events 2 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Surgical and medical procedures Hospitalisation	0.27% 1/370 • Number of events 1 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.00% 0/370 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.

Other adverse events

Measure	Pembrolizumab + SOC n=370 participants at risk Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.	Placebo + SOC n=370 participants at risk Participants received placebo to pembrolizumab (saline) IV Q3W along with SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
Blood and lymphatic system disorders Anaemia	50.0% 185/370 • Number of events 288 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	53.8% 199/370 • Number of events 295 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Leukopenia	6.8% 25/370 • Number of events 56 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.8% 29/370 • Number of events 72 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Neutropenia	25.7% 95/370 • Number of events 190 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	24.3% 90/370 • Number of events 179 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	7.6% 28/370 • Number of events 54 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	10.0% 37/370 • Number of events 57 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Ear and labyrinth disorders Tinnitus	9.7% 36/370 • Number of events 38 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 27/370 • Number of events 30 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hyperthyroidism	5.1% 19/370 • Number of events 19 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	0.81% 3/370 • Number of events 4 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Endocrine disorders Hypothyroidism	10.8% 40/370 • Number of events 46 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.5% 24/370 • Number of events 27 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Abdominal pain	7.6% 28/370 • Number of events 33 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.9% 18/370 • Number of events 21 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	5.4% 20/370 • Number of events 21 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 27/370 • Number of events 41 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Constipation	39.7% 147/370 • Number of events 238 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	40.3% 149/370 • Number of events 210 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Diarrhoea	34.9% 129/370 • Number of events 226 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	32.4% 120/370 • Number of events 190 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Dysphagia	12.4% 46/370 • Number of events 56 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	14.3% 53/370 • Number of events 66 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Nausea	66.2% 245/370 • Number of events 523 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	62.4% 231/370 • Number of events 507 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Stomatitis	26.2% 97/370 • Number of events 160 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	25.1% 93/370 • Number of events 146 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Gastrointestinal disorders Vomiting	32.7% 121/370 • Number of events 226 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	30.8% 114/370 • Number of events 200 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Asthenia	15.7% 58/370 • Number of events 103 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	11.9% 44/370 • Number of events 71 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Chest pain	7.6% 28/370 • Number of events 39 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.4% 20/370 • Number of events 21 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Fatigue	39.7% 147/370 • Number of events 231 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	33.0% 122/370 • Number of events 182 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Malaise	12.2% 45/370 • Number of events 75 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	11.4% 42/370 • Number of events 63 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Mucosal inflammation	15.9% 59/370 • Number of events 114 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	17.6% 65/370 • Number of events 116 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Oedema	5.9% 22/370 • Number of events 59 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.4% 20/370 • Number of events 50 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Oedema peripheral	4.3% 16/370 • Number of events 20 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.8% 29/370 • Number of events 34 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
General disorders Pyrexia	14.3% 53/370 • Number of events 72 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	11.9% 44/370 • Number of events 60 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Pneumonia	5.4% 20/370 • Number of events 21 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.9% 22/370 • Number of events 23 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Upper respiratory tract infection	5.1% 19/370 • Number of events 19 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	4.9% 18/370 • Number of events 19 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Infections and infestations Urinary tract infection	3.2% 12/370 • Number of events 15 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.2% 23/370 • Number of events 26 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Alanine aminotransferase increased	6.5% 24/370 • Number of events 43 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.0% 26/370 • Number of events 32 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Aspartate aminotransferase increased	6.8% 25/370 • Number of events 43 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.3% 27/370 • Number of events 33 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Blood creatinine increased	21.1% 78/370 • Number of events 130 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	20.8% 77/370 • Number of events 115 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Lymphocyte count decreased	6.5% 24/370 • Number of events 52 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.7% 21/370 • Number of events 47 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Neutrophil count decreased	37.3% 138/370 • Number of events 279 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	28.9% 107/370 • Number of events 235 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Platelet count decreased	15.9% 59/370 • Number of events 100 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	15.4% 57/370 • Number of events 96 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations Weight decreased	23.5% 87/370 • Number of events 97 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	24.1% 89/370 • Number of events 110 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Investigations White blood cell count decreased	25.9% 96/370 • Number of events 215 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	18.1% 67/370 • Number of events 154 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	43.8% 162/370 • Number of events 283 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	37.3% 138/370 • Number of events 239 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Dehydration	7.3% 27/370 • Number of events 32 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.8% 25/370 • Number of events 25 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	4.9% 18/370 • Number of events 25 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.1% 19/370 • Number of events 29 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyperkalaemia	7.0% 26/370 • Number of events 47 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.8% 29/370 • Number of events 42 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	9.2% 34/370 • Number of events 43 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	13.2% 49/370 • Number of events 69 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypocalcaemia	7.3% 27/370 • Number of events 34 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.1% 19/370 • Number of events 25 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	17.3% 64/370 • Number of events 107 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	18.4% 68/370 • Number of events 109 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypomagnesaemia	9.2% 34/370 • Number of events 43 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.2% 23/370 • Number of events 29 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	17.0% 63/370 • Number of events 95 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	19.5% 72/370 • Number of events 108 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Metabolism and nutrition disorders Hypophosphataemia	5.4% 20/370 • Number of events 27 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	5.9% 22/370 • Number of events 25 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 30/370 • Number of events 38 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.5% 24/370 • Number of events 26 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	7.3% 27/370 • Number of events 34 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.1% 30/370 • Number of events 35 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Dizziness	9.7% 36/370 • Number of events 42 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.1% 30/370 • Number of events 38 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Dysgeusia	10.5% 39/370 • Number of events 46 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.6% 32/370 • Number of events 35 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Headache	8.1% 30/370 • Number of events 56 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.8% 25/370 • Number of events 30 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Neuropathy peripheral	10.0% 37/370 • Number of events 41 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	10.0% 37/370 • Number of events 43 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Nervous system disorders Peripheral sensory neuropathy	9.7% 36/370 • Number of events 36 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	8.1% 30/370 • Number of events 32 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Psychiatric disorders Insomnia	13.2% 49/370 • Number of events 59 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	11.9% 44/370 • Number of events 56 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	15.9% 59/370 • Number of events 71 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	15.1% 56/370 • Number of events 64 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.2% 34/370 • Number of events 39 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.8% 29/370 • Number of events 29 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Hiccups	15.1% 56/370 • Number of events 112 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	14.3% 53/370 • Number of events 102 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.1% 19/370 • Number of events 21 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.2% 12/370 • Number of events 12 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 22/370 • Number of events 27 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	6.5% 24/370 • Number of events 24 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Alopecia	14.9% 55/370 • Number of events 55 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	10.5% 39/370 • Number of events 40 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Dry skin	5.4% 20/370 • Number of events 21 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	2.7% 10/370 • Number of events 10 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	8.4% 31/370 • Number of events 33 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	3.2% 12/370 • Number of events 13 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Skin and subcutaneous tissue disorders Rash	11.9% 44/370 • Number of events 56 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.0% 26/370 • Number of events 33 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Vascular disorders Hypertension	6.2% 23/370 • Number of events 24 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.	7.8% 29/370 • Number of events 35 • Up to approximately 70 months All-Cause Mortality table includes all randomized participants, Serious and Other AE tables include all treated participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were 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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER