Trial Outcomes & Findings for Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) (NCT NCT02578680)

Last Updated: 2024-09-20

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

616 participants

Primary outcome timeframe

Up to approximately 21 months

Results posted on

2024-09-20

Participant Flow

Eighty-four participants randomized to receive Control switched over to receive pembrolizumab monotherapy. Participants receiving pembrolizumab in first course and those switching over from placebo to pembrolizumab monotherapy were eligible to receive second course of pembrolizumab monotherapy if they met certain criteria. Data from second course treatment contributed to safety data only. All primary and secondary outcome measures are based on protocol-specified cutoff (2017-11-08).

Participant milestones

Participant milestones
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Overall Study STARTED	410	206
Overall Study Treated	405	202
Overall Study Switched to Pembrolizumab	0	84
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	410	206

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Overall Study Death	329	181
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	1	1
Overall Study Sponsor Decision	64	13
Overall Study Withdrawal by Subject	13	9

Baseline Characteristics

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=410 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=206 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)	Total n=616 Participants Total of all reporting groups
Age, Continuous	63.2 Years STANDARD_DEVIATION 9.4 • n=5 Participants	62.8 Years STANDARD_DEVIATION 9.1 • n=7 Participants	63.1 Years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	156 Participants n=5 Participants	97 Participants n=7 Participants	253 Participants n=5 Participants
Sex: Female, Male Male	254 Participants n=5 Participants	109 Participants n=7 Participants	363 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	8 Participants n=7 Participants	18 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	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	387 Participants n=5 Participants	195 Participants n=7 Participants	582 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status TPS <1%	127 Participants n=5 Participants	63 Participants n=7 Participants	190 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status TPS ≥1%	260 Participants n=5 Participants	128 Participants n=7 Participants	388 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status Not Evaluable	23 Participants n=5 Participants	15 Participants n=7 Participants	38 Participants n=5 Participants
Platinum Chemotherapy Cisplatin	113 Participants n=5 Participants	58 Participants n=7 Participants	171 Participants n=5 Participants
Platinum Chemotherapy Carboplatin	297 Participants n=5 Participants	148 Participants n=7 Participants	445 Participants n=5 Participants
Smoking Status Never Smoker	48 Participants n=5 Participants	25 Participants n=7 Participants	73 Participants n=5 Participants
Smoking Status Former/Current Smoker	362 Participants n=5 Participants	181 Participants n=7 Participants	543 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 21 months

Population: The analysis population consisted of all randomized participants.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=410 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=206 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging	8.8 Months Interval 7.6 to 9.2	4.9 Months Interval 4.7 to 5.5

PRIMARY outcome

Timeframe: Up to approximately 21 months

Population: The analysis population consisted of all randomized participants.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=410 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=206 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Overall Survival (OS)	NA Months NA=Median OS not reached NA=Lower Limit OS not reached NA=Upper Limit OS not reached	11.3 Months Interval 8.7 to 15.1

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The analysis population consisted of all randomized participants.

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, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=410 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=206 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging	47.6 Percentage of Participants Interval 42.6 to 52.5	18.9 Percentage of Participants Interval 13.8 to 25.0

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The analysis population consisted of all randomized participants who experienced a confirmed CR or confirmed PR.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=195 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=39 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging	11.2 Months Interval 1.1 to 18.0	7.8 Months Interval 2.1 to 16.4

SECONDARY outcome

Timeframe: Up to approximately 21 months (Serious AEs: Up to 90 days after last dose of study treatment; Other AEs: Up to 30 days after last dose of study treatment)

Population: The analysis population consisted of all randomized participants who received ≥1 dose of study drug.

An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. The number of participants who experienced an AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=405 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=202 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Number of Participants Who Experienced an Adverse Event (AE)	404 Participants	200 Participants

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The analysis population consisted of all randomized participants who received ≥1 dose of study drug.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=405 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=202 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Number of Participants Who Discontinued Any Study Drug Due to an AE	112 Participants	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 39 months

Population: The analysis population consisted of all randomized participants.

PFS was defined as the time from randomization to the first documented immune-related progressive disease (irPD) or death due to any cause, whichever occurred first. Per irRECIST, irPD was confirmed if any of the following are observed in 2 scans performed at least 4 weeks apart: target lesion sum of diameters remains ≥20 % and at least 5 mm absolute increase compared to nadir; non-target disease resulting in initial PD is qualitatively worse; new lesion resulting in initial irPD is qualitatively worse; additional new lesion(s) since last evaluation; or additional new non-target lesion progression since last evaluation. The PFS per irRECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=410 Participants Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=206 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria	10.3 Months Interval 9.0 to 11.3	5.0 Months Interval 4.8 to 6.0

Adverse Events

Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed

Serious events: 233 serious events

Other events: 395 other events

Deaths: 330 deaths

Control

Serious events: 102 serious events

Other events: 196 other events

Deaths: 113 deaths

Control Switched Over to Pembrolizumab Monotherapy

Serious events: 29 serious events

Other events: 64 other events

Deaths: 74 deaths

Control Switched Over to Pembrolizumab Monotherapy (Second Course)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=405 participants at risk Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=202 participants at risk Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)	Control Switched Over to Pembrolizumab Monotherapy n=84 participants at risk Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.	Control Switched Over to Pembrolizumab Monotherapy (Second Course) n=2 participants at risk Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course) n=9 participants at risk Participants who received pembrolizumab PLUS pemetrexed and platinum chemotherapy followed by pembrolizumab PLUS pemetrexed during the initial treatment but experienced disease progression, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.
Blood and lymphatic system disorders Anaemia	3.2% 13/405 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.4% 11/202 • Number of events 12 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Febrile neutropenia	6.2% 25/405 • Number of events 26 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Lymphadenopathy	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	2.7% 11/405 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Pancytopenia	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	3.2% 13/405 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.0% 6/202 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Acute myocardial infarction	0.25% 1/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.5% 3/202 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Atrial flutter	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiac arrest	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiac failure	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiopulmonary failure	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Left ventricular dysfunction	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Myocardial infarction	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Myopericarditis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Pericardial effusion	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Pericarditis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Sinus tachycardia	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Stress cardiomyopathy	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Supraventricular tachycardia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Ventricular arrhythmia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Adrenal insufficiency	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal adhesions	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Colitis	1.2% 5/405 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	0.74% 3/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	3.5% 14/405 • Number of events 16 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 8 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Duodenitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastritis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastrointestinal perforation	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Intestinal ischaemia	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Intussusception	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Lip oedema	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Melaena	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Mesenteric artery embolism	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	1.2% 5/405 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.5% 7/202 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Oesophagitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Pancreatitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Pancreatitis acute	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Pancreatitis chronic	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Small intestinal haemorrhage	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Stomatitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	1.7% 7/405 • Number of events 8 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Asthenia	1.5% 6/405 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Chest pain	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Death	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Fatigue	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders General physical health deterioration	1.5% 6/405 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Inflammation	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Influenza like illness	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Localised oedema	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Malaise	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Mucosal inflammation	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Multiple organ dysfunction syndrome	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Oedema peripheral	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	2.2% 9/405 • Number of events 10 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Autoimmune hepatitis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Bile duct stone	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Cholangitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Cholangitis sclerosing	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Cholecystitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Hepatic pain	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Hepatitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Immune-mediated hepatitis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Immune system disorders Cytokine release syndrome	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Abdominal sepsis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Appendicitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Arthritis bacterial	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Bacillus bacteraemia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Bacteraemia	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Bacterial colitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Bronchitis	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.5% 3/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations CNS ventriculitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations COVID-19 pneumonia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Cellulitis	1.2% 5/405 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Clostridium difficile colitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Clostridium difficile infection	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Diabetic foot infection	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Diverticulitis	0.25% 1/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Empyema	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Encephalitis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Endocarditis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Enteritis infectious	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Erysipelas	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Folliculitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Gastroenteritis	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Herpes zoster	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Infected dermal cyst	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Infection	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Infectious pleural effusion	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Influenza	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Kidney infection	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Lower respiratory tract infection	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Lung abscess	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Neutropenic sepsis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Oral candidiasis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Otitis media	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Parotitis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Peritonitis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumococcal sepsis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumocystis jirovecii pneumonia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	8.4% 34/405 • Number of events 35 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.9% 18/202 • Number of events 21 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia aspiration	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia bacterial	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia influenzal	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia viral	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pulmonary sepsis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pyelonephritis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Respiratory tract infection	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Salmonella bacteraemia	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Sepsis	1.7% 7/405 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Septic shock	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Tuberculosis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Tuberculous pleurisy	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	1.5% 6/405 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection bacterial	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	1.2% 5/405 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urosepsis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Accidental overdose	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Craniocerebral injury	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Dislocation of vertebra	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Fall	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Femur fracture	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Hip fracture	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Limb traumatic amputation	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Post procedural diarrhoea	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Radiation oesophagitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Shoulder fracture	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Spinal compression fracture	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Spinal fracture	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Toxicity to various agents	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Wrist fracture	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood calcium decreased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood magnesium decreased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations C-reactive protein increased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Hepatic enzyme increased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Platelet count decreased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Dehydration	1.2% 5/405 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypomagnesaemia	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Malnutrition	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Polydipsia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.25% 1/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Hypertrophic osteoarthropathy	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Myalgia	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Osteolysis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.25% 1/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pathological fracture	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tracheal neoplasm	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Balance disorder	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Brain stem infarction	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Central nervous system vasculitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebral haemorrhage	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebral infarction	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Demyelinating polyneuropathy	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Dizziness	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Encephalopathy	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Haemorrhage intracranial	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Hemiparesis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Hydrocephalus	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Intracranial aneurysm	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Ischaemic stroke	0.49% 2/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Lacunar stroke	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Lumbar radiculopathy	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Partial seizures	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Seizure	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Spinal cord compression	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Syncope	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Transient ischaemic attack	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Product Issues Device dislocation	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Anxiety	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Confusional state	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Delirium	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Depression	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Disorientation	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Major depression	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Acute kidney injury	2.7% 11/405 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Autoimmune nephritis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Chronic kidney disease	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Haematuria	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Nephritis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Prerenal failure	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Renal failure	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Renal tubular necrosis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Tubulointerstitial nephritis	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Urinary retention	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Urinary tract obstruction	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Reproductive system and breast disorders Balanoposthitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Reproductive system and breast disorders Scrotal cyst	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 6/405 • Number of events 8 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.5% 3/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 6/405 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.5% 3/202 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Hiccups	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.2% 13/405 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 13/405 • Number of events 13 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 5/405 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.6% 3/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.25% 1/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash papular	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Skin sensitisation	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Aortic stenosis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Deep vein thrombosis	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Hypertension	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Jugular vein thrombosis	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Peripheral artery occlusion	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Vena cava thrombosis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Venous occlusion	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.

Other adverse events

Other adverse events
Measure	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed n=405 participants at risk Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)	Control n=202 participants at risk Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)	Control Switched Over to Pembrolizumab Monotherapy n=84 participants at risk Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.	Control Switched Over to Pembrolizumab Monotherapy (Second Course) n=2 participants at risk Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course) n=9 participants at risk Participants who received pembrolizumab PLUS pemetrexed and platinum chemotherapy followed by pembrolizumab PLUS pemetrexed during the initial treatment but experienced disease progression, and met certain criteria, received a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.
Nervous system disorders Radiculopathy	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Insomnia	7.7% 31/405 • Number of events 35 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.4% 17/202 • Number of events 17 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Proteinuria	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Anaemia	45.9% 186/405 • Number of events 253 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	45.0% 91/202 • Number of events 114 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.1% 6/84 • Number of events 8 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	6.4% 26/405 • Number of events 44 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.4% 13/202 • Number of events 18 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	26.7% 108/405 • Number of events 213 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	24.3% 49/202 • Number of events 92 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	16.8% 68/405 • Number of events 108 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	12.4% 25/202 • Number of events 37 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Ear and labyrinth disorders Ear discomfort	0.74% 3/405 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Ear and labyrinth disorders Otorrhoea	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Ear and labyrinth disorders Tinnitus	3.5% 14/405 • Number of events 19 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.4% 11/202 • Number of events 12 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Ear and labyrinth disorders Vertigo	4.2% 17/405 • Number of events 21 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	7.7% 31/405 • Number of events 38 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.1% 6/84 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Eye disorders Dry eye	5.2% 21/405 • Number of events 23 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Eye disorders Lacrimation increased	18.5% 75/405 • Number of events 87 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	10.9% 22/202 • Number of events 24 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	9.6% 39/405 • Number of events 49 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.4% 13/202 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.3% 7/84 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	7.2% 29/405 • Number of events 31 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	35.3% 143/405 • Number of events 220 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	33.2% 67/202 • Number of events 87 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.3% 7/84 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	30.4% 123/405 • Number of events 179 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	20.3% 41/202 • Number of events 54 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	13.1% 11/84 • Number of events 19 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Dyspepsia	6.9% 28/405 • Number of events 31 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.4% 11/202 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.2% 17/405 • Number of events 18 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.0% 6/202 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	57.3% 232/405 • Number of events 430 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	51.0% 103/202 • Number of events 186 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	19.0% 16/84 • Number of events 18 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Stomatitis	9.1% 37/405 • Number of events 54 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.9% 16/202 • Number of events 21 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	25.7% 104/405 • Number of events 183 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	21.3% 43/202 • Number of events 70 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.3% 12/84 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Asthenia	21.0% 85/405 • Number of events 158 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	23.3% 47/202 • Number of events 74 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.1% 6/84 • Number of events 8 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Chest pain	9.4% 38/405 • Number of events 44 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.9% 12/202 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.1% 6/84 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Fatigue	42.7% 173/405 • Number of events 285 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	39.6% 80/202 • Number of events 127 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.5% 8/84 • Number of events 9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Mucosal inflammation	9.1% 37/405 • Number of events 48 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.9% 16/202 • Number of events 24 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Oedema peripheral	25.4% 103/405 • Number of events 180 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	17.3% 35/202 • Number of events 48 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	13.1% 11/84 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Pain	5.4% 22/405 • Number of events 22 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.5% 7/202 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	20.7% 84/405 • Number of events 118 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	14.9% 30/202 • Number of events 47 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.1% 6/84 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Bronchitis	5.7% 23/405 • Number of events 29 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.0% 6/202 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Conjunctivitis	9.1% 37/405 • Number of events 48 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.9% 18/202 • Number of events 33 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Ear infection	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Herpes zoster	2.7% 11/405 • Number of events 12 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Nasopharyngitis	11.6% 47/405 • Number of events 76 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.0% 10/202 • Number of events 12 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.0% 5/84 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Otitis externa	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	5.2% 21/405 • Number of events 29 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.0% 6/202 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Sinusitis	2.5% 10/405 • Number of events 12 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	10.9% 44/405 • Number of events 59 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.9% 16/202 • Number of events 17 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	8.4% 34/405 • Number of events 47 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.4% 13/202 • Number of events 17 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Contusion	1.5% 6/405 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.50% 1/202 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Skin abrasion	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	12.3% 50/405 • Number of events 63 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.4% 19/202 • Number of events 23 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	9.9% 40/405 • Number of events 57 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.4% 13/202 • Number of events 16 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.0% 5/84 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood alkaline phosphatase increased	4.0% 16/405 • Number of events 21 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.5% 9/202 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood bilirubin increased	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood creatinine increased	14.3% 58/405 • Number of events 97 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.4% 17/202 • Number of events 29 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 10 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood magnesium decreased	0.99% 4/405 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Tri-iodothyronine increased	0.00% 0/405 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations Weight decreased	10.9% 44/405 • Number of events 59 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.9% 16/202 • Number of events 17 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Investigations White blood cell count decreased	6.9% 28/405 • Number of events 57 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.4% 13/202 • Number of events 20 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	30.1% 122/405 • Number of events 172 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	31.2% 63/202 • Number of events 81 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	20.2% 17/84 • Number of events 19 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	8.4% 34/405 • Number of events 49 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.5% 7/202 • Number of events 10 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	12.6% 51/405 • Number of events 91 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.9% 16/202 • Number of events 20 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 37/405 • Number of events 54 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.0% 8/202 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypophosphataemia	5.9% 24/405 • Number of events 38 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.5% 5/202 • Number of events 13 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	17.3% 70/405 • Number of events 99 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	13.9% 28/202 • Number of events 33 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.9% 10/84 • Number of events 12 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	17.5% 71/405 • Number of events 86 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	12.9% 26/202 • Number of events 29 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.3% 7/84 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.7% 19/405 • Number of events 23 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.5% 7/202 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.5% 10/405 • Number of events 13 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.0% 8/202 • Number of events 9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	4.0% 16/405 • Number of events 16 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.0% 6/202 • Number of events 8 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/405 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/202 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	50.0% 1/2 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 37/405 • Number of events 47 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.9% 18/202 • Number of events 18 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.1% 6/84 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Dizziness	14.3% 58/405 • Number of events 64 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	10.9% 22/202 • Number of events 27 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Dysgeusia	8.9% 36/405 • Number of events 41 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	8.4% 17/202 • Number of events 17 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Headache	14.1% 57/405 • Number of events 72 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	10.9% 22/202 • Number of events 29 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.0% 5/84 • Number of events 7 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Paraesthesia	5.9% 24/405 • Number of events 33 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.9% 14/202 • Number of events 21 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	25.7% 104/405 • Number of events 139 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	30.7% 62/202 • Number of events 71 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	10.7% 9/84 • Number of events 13 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	24.0% 97/405 • Number of events 118 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	25.2% 51/202 • Number of events 59 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	17.9% 15/84 • Number of events 20 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.2% 29/405 • Number of events 35 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.5% 7/202 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.5% 14/405 • Number of events 16 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	7.9% 16/202 • Number of events 20 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.4% 2/84 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 27/405 • Number of events 33 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.0% 6/202 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 27/405 • Number of events 33 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.5% 9/202 • Number of events 10 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.6% 3/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.2% 25/405 • Number of events 28 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.0% 10/202 • Number of events 10 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Wheezing	2.5% 10/405 • Number of events 11 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Alopecia	5.4% 22/405 • Number of events 24 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.0% 10/202 • Number of events 10 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Dry skin	6.7% 27/405 • Number of events 28 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	9.9% 20/202 • Number of events 22 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Erythema	7.4% 30/405 • Number of events 38 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 5 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	3.6% 3/84 • Number of events 3 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	14.6% 59/405 • Number of events 80 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.4% 23/202 • Number of events 25 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	22.0% 89/405 • Number of events 131 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	13.4% 27/202 • Number of events 36 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	4.8% 4/84 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Skin ulcer	0.49% 2/405 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.99% 2/202 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/84 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Hypertension	5.7% 23/405 • Number of events 25 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	5.4% 11/202 • Number of events 14 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	6.0% 5/84 • Number of events 6 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Hypotension	5.9% 24/405 • Number of events 27 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	2.0% 4/202 • Number of events 4 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	1.2% 1/84 • Number of events 1 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/2 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/9 • Up to approximately 88 months Safety Population: All participants receiving ≥1 dose of randomized study drug. All-Cause Mortality Population: All randomized participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER