Trial Outcomes & Findings for A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008) (NCT NCT03976362)

NCT ID: NCT03976362

Last Updated: 2025-10-16

Results Overview

Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (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 have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 851 participants
• Primary outcome timeframe: Up to approximately 39 months
• Results posted on: 2025-10-16

Participant Flow

Study consisted of an Induction, Maintenance and Posttreatment phase. For induction, eligible participants were enrolled to receive pembrolizumab and carboplatin plus paclitaxel or nab-paclitaxel. Participants who met additional criteria were randomized 1:1 into a maintenance phase to receive either pembrolizumab combined with olaparib or pembrolizumab combined with placebo. In the posttreatment phase, participants were either followed up or administered a second course of pembrolizumab.

Participant milestones

Measure	Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase) Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m\^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m\^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.	Pembro + Olaparib (Maintenance Phase) This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Induction Phase STARTED	851	0	0
Induction Phase COMPLETED	591	0	0
Induction Phase NOT COMPLETED	260	0	0
Maintenance Phase STARTED	0	296	295
Maintenance Phase Pembro + Olaparib/Placebo (Second Course Pembro Only)	0	7	9
Maintenance Phase COMPLETED	0	0	0
Maintenance Phase NOT COMPLETED	0	296	295

Reasons for withdrawal

Measure	Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase) Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m\^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m\^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.	Pembro + Olaparib (Maintenance Phase) This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Induction Phase Failure to Meet Maintenance Randomization Criteria	198	0	0
Induction Phase Death	62	0	0
Maintenance Phase Participants Ongoing	0	106	103
Maintenance Phase Withdrawal by Subject	0	4	4
Maintenance Phase Failure To Meet Randomization Criteria	0	0	1
Maintenance Phase Death	0	186	187

Baseline Characteristics

Data for this baseline measure were not collected for the induction phase per protocol.

Baseline characteristics by cohort

Measure	Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase) n=260 Participants Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m\^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m\^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.	Pembro + Olaparib (Maintenance Phase) n=296 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=295 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Total n=851 Participants Total of all reporting groups
Age, Continuous	65.5 Years STANDARD_DEVIATION 8.6 • n=260 Participants	64.2 Years STANDARD_DEVIATION 8.8 • n=296 Participants	64.6 Years STANDARD_DEVIATION 7.8 • n=295 Participants	64.4 Years STANDARD_DEVIATION 8.4 • n=851 Participants
Sex: Female, Male Female	55 Participants n=260 Participants	55 Participants n=296 Participants	60 Participants n=295 Participants	170 Participants n=851 Participants
Sex: Female, Male Male	205 Participants n=260 Participants	241 Participants n=296 Participants	235 Participants n=295 Participants	681 Participants n=851 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=260 Participants	47 Participants n=296 Participants	48 Participants n=295 Participants	129 Participants n=851 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	211 Participants n=260 Participants	239 Participants n=296 Participants	235 Participants n=295 Participants	685 Participants n=851 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=260 Participants	10 Participants n=296 Participants	12 Participants n=295 Participants	37 Participants n=851 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=260 Participants	9 Participants n=296 Participants	11 Participants n=295 Participants	25 Participants n=851 Participants
Race (NIH/OMB) Asian	76 Participants n=260 Participants	63 Participants n=296 Participants	51 Participants n=295 Participants	190 Participants n=851 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=260 Participants	0 Participants n=296 Participants	1 Participants n=295 Participants	1 Participants n=851 Participants
Race (NIH/OMB) Black or African American	4 Participants n=260 Participants	4 Participants n=296 Participants	3 Participants n=295 Participants	11 Participants n=851 Participants
Race (NIH/OMB) White	164 Participants n=260 Participants	214 Participants n=296 Participants	219 Participants n=295 Participants	597 Participants n=851 Participants
Race (NIH/OMB) More than one race	2 Participants n=260 Participants	1 Participants n=296 Participants	3 Participants n=295 Participants	6 Participants n=851 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=260 Participants	5 Participants n=296 Participants	7 Participants n=295 Participants	21 Participants n=851 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade 0	0 Participants Data for this baseline measure were not collected for the induction phase per protocol.	83 Participants n=296 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	82 Participants n=295 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	165 Participants n=591 Participants • Data for this baseline measure were not collected for the induction phase per protocol.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade 1	0 Participants Data for this baseline measure were not collected for the induction phase per protocol.	213 Participants n=296 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	213 Participants n=295 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	426 Participants n=591 Participants • Data for this baseline measure were not collected for the induction phase per protocol.
Response Complete Response (CR)l/Partial Response (PR)	0 Participants Data for this baseline measure were not collected for the induction phase per protocol.	211 Participants n=296 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	218 Participants n=295 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	429 Participants n=591 Participants • Data for this baseline measure were not collected for the induction phase per protocol.
Response Stable Disease (SD)	0 Participants Data for this baseline measure were not collected for the induction phase per protocol.	84 Participants n=296 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	76 Participants n=295 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	160 Participants n=591 Participants • Data for this baseline measure were not collected for the induction phase per protocol.
Response Progressive Disease (PD)	0 Participants Data for this baseline measure were not collected for the induction phase per protocol.	1 Participants n=296 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	0 Participants n=295 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	1 Participants n=591 Participants • Data for this baseline measure were not collected for the induction phase per protocol.
Response Missing	0 Participants Data for this baseline measure were not collected for the induction phase per protocol.	0 Participants n=296 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	1 Participants n=295 Participants • Data for this baseline measure were not collected for the induction phase per protocol.	1 Participants n=591 Participants • Data for this baseline measure were not collected for the induction phase per protocol.
Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS) Tumor Proportion Score (TPS)<50%	187 Participants n=260 Participants	208 Participants n=296 Participants	208 Participants n=295 Participants	603 Participants n=851 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS) TPS≥50%	64 Participants n=260 Participants	85 Participants n=296 Participants	85 Participants n=295 Participants	234 Participants n=851 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS) Not Evaluable	5 Participants n=260 Participants	2 Participants n=296 Participants	2 Participants n=295 Participants	9 Participants n=851 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS) Missing	4 Participants n=260 Participants	1 Participants n=296 Participants	0 Participants n=295 Participants	5 Participants n=851 Participants

PRIMARY outcome

Timeframe: Up to approximately 39 months

Population: The analysis population consisted of all randomized participants.

Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (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 have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=296 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=295 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Progression-free Survival (PFS)	8.3 Months Interval 6.7 to 9.7	5.4 Months Interval 4.1 to 5.6

PRIMARY outcome

Timeframe: Up to approximately 46 months

Population: The analysis population consisted of all randomized participants.

Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=296 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=295 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Overall Survival (OS)	19.1 Months Interval 15.9 to 22.2	18.6 Months Interval 16.0 to 21.6

SECONDARY outcome

Timeframe: Up to approximately 4 years

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 4 years

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=293 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=291 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score	-1.24 Score on a Scale Interval -3.68 to 1.19	-1.62 Score on a Scale Interval -4.11 to 0.88

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10- point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=285 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=283 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score	29.08 Months Interval 17.94 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	29.01 Months Interval 12.55 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=293 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=291 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score	2.42 Score on a Scale Interval -0.93 to 5.77	0.74 Score on a Scale Interval -2.69 to 4.17

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=285 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=283 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score	24.18 Months Interval 15.64 to Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 16.56 to Median and Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=293 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=291 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score	6.35 Score on a Scale Interval 3.95 to 8.76	2.52 Score on a Scale Interval 0.06 to 4.98

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=285 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=283 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score	NA Months Median, Lower and Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Median, Lower and Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=293 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=291 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score	-1.08 Score on a Scale Interval -4.49 to 2.34	-1.25 Score on a Scale Interval -4.74 to 2.24

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=285 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=283 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score	NA Months Median, Lower and Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 14.72 to Median and Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=285 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=283 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score	-2.04 Score on Scale Interval -4.38 to 0.31	0.77 Score on Scale Interval -1.62 to 3.17

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.

Outcome measures

Measure	Pembro + Olaparib (Maintenance Phase) n=285 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Placebo (Maintenance Phase) n=283 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score	22.80 Months Interval 10.05 to Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 27.5 to Median and Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.

Adverse Events

Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)

Serious events: 220 serious events

Other events: 787 other events

Deaths: 101 deaths

Pembro+Olaparib (Maintenance Phase )

Serious events: 97 serious events

Other events: 265 other events

Deaths: 188 deaths

Pembro+Placebo (Maintenance Phase)

Serious events: 77 serious events

Other events: 240 other events

Deaths: 189 deaths

Pembro + Olaparib (Second Course Pembro Only)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Pembro + Placebo (Second Course Pembro Only)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Measure	Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase) n=851 participants at risk Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m\^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m\^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.	Pembro+Olaparib (Maintenance Phase ) n=294 participants at risk This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro+Placebo (Maintenance Phase) n=292 participants at risk This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Olaparib (Second Course Pembro Only) n=7 participants at risk Eligible participants who received 35 cycles of Pembrolizumab and progressed with SD, PR, or CR in either arm were eligible for an optional 1 additional year (17 cycles) of Pembrolizumab.	Pembro + Placebo (Second Course Pembro Only) n=9 participants at risk Eligible participants who received 35 cycles of Pembrolizumab and progressed with SD, PR, or CR in either arm were eligible for an optional 1 additional year (17 cycles) of Pembrolizumab.
Blood and lymphatic system disorders Anaemia	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.4% 10/294 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 14/851 • Number of events 14 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	1.3% 11/851 • Number of events 11 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.71% 6/851 • Number of events 6 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/294 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/292 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Acute coronary syndrome	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Acute myocardial infarction	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Angina pectoris	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/294 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardiac failure	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Myocardial infarction	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Pericardial effusion	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Adrenal insufficiency	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/294 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hypothyroidism	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Eye disorders Cataract	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	1.2% 10/851 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/294 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Inguinal hernia	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intestinal perforation	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chest discomfort	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Death	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Fatigue	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Multiple organ dysfunction syndrome	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	0.94% 8/851 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Cholangitis acute	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Cholecystitis	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Cholecystitis acute	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hepatitis	0.71% 6/851 • Number of events 6 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Liver injury	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Bacteraemia	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Bronchitis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations COVID-19	0.94% 8/851 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.1% 9/294 • Number of events 9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations COVID-19 pneumonia	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.4% 10/294 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 8/292 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Carbuncle	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Cellulitis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Device related infection	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Enterocolitis infectious	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Hepatitis C	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Herpes zoster disseminated	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Lung abscess	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pelvic abscess	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	4.2% 36/851 • Number of events 41 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.4% 13/294 • Number of events 14 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.8% 11/292 • Number of events 12 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia aspiration	0.59% 5/851 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia bacterial	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Septic shock	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Soft tissue infection	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Upper respiratory tract infection	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Urinary tract infection	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Femur fracture	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Shoulder fracture	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Traumatic lung injury	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Alanine aminotransferase increased	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Aspartate aminotransferase increased	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood creatinine increased	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Troponin increased	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Brain oedema	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebral haematoma	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.24% 2/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Facial nerve disorder	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Headache	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Hepatic encephalopathy	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Ischaemic stroke	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Myoclonus	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Psychiatric disorders Suicide attempt	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.94% 8/851 • Number of events 9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Nephritis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Nephrolithiasis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Nephropathy	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Renal failure	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.35% 3/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/292 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.59% 5/851 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.4% 7/294 • Number of events 7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/292 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/294 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.59% 5/851 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.0% 3/294 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypertensive crisis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Peripheral artery thrombosis	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/292 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Superior vena cava syndrome	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Angina unstable	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Atrial flutter	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardiac failure acute	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardiac failure congestive	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardiac ventricular thrombosis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Cardiopulmonary failure	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Cardiac disorders Myocarditis	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Congenital, familial and genetic disorders Hydrocele	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hyperthyroidism	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hypophysitis	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Colitis	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Constipation	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Dysphagia	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Enteritis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastritis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Ileus	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Oesophagitis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Chest pain	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders General physical health deterioration	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Sudden cardiac death	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Autoimmune hepatitis	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Cholangitis	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Drug-induced liver injury	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hepatic function abnormal	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hepatotoxicity	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Hyperbilirubinaemia	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Hepatobiliary disorders Immune-mediated hepatitis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Immune system disorders Anaphylactic shock	0.24% 2/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Immune system disorders Hypersensitivity	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Herpes zoster	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Liver abscess	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Lower respiratory tract infection	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Mediastinitis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Meningitis cryptococcal	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Oral candidiasis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia pneumococcal	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Rash pustular	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Respiratory tract infection	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Sepsis	0.59% 5/851 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Eastern Cooperative Oncology Group performance status worsened	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Dehydration	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.35% 3/851 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypervolaemia	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Malnutrition	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Steroid diabetes	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pathological fracture	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Cerebral haemorrhage	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Dizziness	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Haemorrhage intracranial	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Hypoaesthesia	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Neuropathy peripheral	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Seizure	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Stupor	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Syncope	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Toxic neuropathy	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Psychiatric disorders Confusional state	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Psychiatric disorders Depression	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Autoimmune nephritis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Chronic kidney disease	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Renal impairment	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Tubulointerstitial nephritis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Reproductive system and breast disorders Orchitis noninfective	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Hiccups	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Dermatitis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Deep vein thrombosis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Embolism	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypotension	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Peripheral arterial occlusive disease	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Subclavian artery stenosis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.

Other adverse events

Measure	Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase) n=851 participants at risk Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m\^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m\^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.	Pembro+Olaparib (Maintenance Phase ) n=294 participants at risk This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro+Placebo (Maintenance Phase) n=292 participants at risk This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.	Pembro + Olaparib (Second Course Pembro Only) n=7 participants at risk Eligible participants who received 35 cycles of Pembrolizumab and progressed with SD, PR, or CR in either arm were eligible for an optional 1 additional year (17 cycles) of Pembrolizumab.	Pembro + Placebo (Second Course Pembro Only) n=9 participants at risk Eligible participants who received 35 cycles of Pembrolizumab and progressed with SD, PR, or CR in either arm were eligible for an optional 1 additional year (17 cycles) of Pembrolizumab.
Blood and lymphatic system disorders Anaemia	43.4% 369/851 • Number of events 432 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	44.2% 130/294 • Number of events 215 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	15.4% 45/292 • Number of events 69 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	19.7% 168/851 • Number of events 299 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	15.0% 44/294 • Number of events 115 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.5% 13/292 • Number of events 19 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Lymphopenia	2.7% 23/851 • Number of events 28 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.1% 21/294 • Number of events 39 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.8% 11/292 • Number of events 13 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	32.8% 279/851 • Number of events 520 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	19.4% 57/294 • Number of events 118 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.5% 16/292 • Number of events 25 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	23.5% 200/851 • Number of events 314 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	19.0% 56/294 • Number of events 127 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.5% 19/292 • Number of events 43 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Endocrine disorders Hypothyroidism	2.9% 25/851 • Number of events 25 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.8% 23/294 • Number of events 24 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.6% 34/292 • Number of events 38 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Constipation	17.3% 147/851 • Number of events 165 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.8% 26/294 • Number of events 30 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.9% 29/292 • Number of events 30 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Diarrhoea	13.2% 112/851 • Number of events 148 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.8% 23/294 • Number of events 32 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.3% 33/292 • Number of events 49 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Nausea	25.3% 215/851 • Number of events 346 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	23.5% 69/294 • Number of events 98 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.0% 35/292 • Number of events 51 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Vomiting	7.8% 66/851 • Number of events 75 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.8% 26/294 • Number of events 34 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.8% 11/292 • Number of events 15 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	13.5% 115/851 • Number of events 138 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 42/294 • Number of events 50 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.7% 37/292 • Number of events 47 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Fatigue	12.3% 105/851 • Number of events 136 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.9% 32/294 • Number of events 36 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.7% 40/292 • Number of events 44 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Pyrexia	8.7% 74/851 • Number of events 83 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.1% 18/294 • Number of events 21 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.5% 16/292 • Number of events 20 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations COVID-19	0.71% 6/851 • Number of events 6 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.4% 13/294 • Number of events 13 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.5% 19/292 • Number of events 20 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	2.7% 23/851 • Number of events 26 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.8% 17/294 • Number of events 19 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.8% 11/292 • Number of events 21 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Alanine aminotransferase increased	6.3% 54/851 • Number of events 59 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.5% 25/294 • Number of events 32 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.9% 29/292 • Number of events 50 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Aspartate aminotransferase increased	4.6% 39/851 • Number of events 45 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.5% 25/294 • Number of events 27 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.2% 27/292 • Number of events 42 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood alkaline phosphatase increased	4.5% 38/851 • Number of events 40 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.1% 21/294 • Number of events 31 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.5% 22/292 • Number of events 33 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Blood creatinine increased	3.6% 31/851 • Number of events 37 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.8% 26/294 • Number of events 41 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.8% 17/292 • Number of events 39 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Weight decreased	4.2% 36/851 • Number of events 37 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	4.8% 14/294 • Number of events 14 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.1% 15/292 • Number of events 16 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	16.5% 140/851 • Number of events 166 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	18.4% 54/294 • Number of events 62 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	16.1% 47/292 • Number of events 53 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	3.9% 33/851 • Number of events 35 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.2% 24/294 • Number of events 51 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.2% 21/292 • Number of events 37 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperkalaemia	3.6% 31/851 • Number of events 34 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.1% 15/294 • Number of events 24 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.5% 22/292 • Number of events 40 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	4.8% 41/851 • Number of events 50 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.7% 5/294 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.2% 18/292 • Number of events 29 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 65/851 • Number of events 102 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.9% 29/294 • Number of events 35 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.0% 32/292 • Number of events 47 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	1.8% 15/851 • Number of events 16 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.8% 20/294 • Number of events 24 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.2% 21/292 • Number of events 23 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Myalgia	8.8% 75/851 • Number of events 114 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.1% 9/294 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.5% 16/292 • Number of events 18 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Dizziness	2.9% 25/851 • Number of events 26 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.8% 17/294 • Number of events 21 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.8% 11/292 • Number of events 11 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Headache	2.2% 19/851 • Number of events 20 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	6.8% 20/294 • Number of events 27 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.2% 21/292 • Number of events 26 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	4.1% 35/851 • Number of events 35 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.2% 36/294 • Number of events 46 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.7% 37/292 • Number of events 40 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.3% 37/851 • Number of events 38 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.9% 29/294 • Number of events 33 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.0% 32/292 • Number of events 35 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.9% 25/851 • Number of events 28 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.4% 10/294 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.8% 17/292 • Number of events 23 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	6.5% 55/851 • Number of events 59 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.5% 22/294 • Number of events 30 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.2% 27/292 • Number of events 30 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	7.4% 63/851 • Number of events 66 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.5% 22/294 • Number of events 23 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	8.2% 24/292 • Number of events 31 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	2.1% 18/851 • Number of events 18 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 8/294 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.4% 7/292 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Malaise	3.2% 27/851 • Number of events 35 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/294 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Bronchitis	1.2% 10/851 • Number of events 11 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/294 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/292 • Number of events 6 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Herpes zoster	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Influenza	0.47% 4/851 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/294 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/292 • Number of events 4 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Nasopharyngitis	1.2% 10/851 • Number of events 10 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.1% 9/294 • Number of events 11 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.4% 7/292 • Number of events 9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Sinusitis	0.35% 3/851 • Number of events 3 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.4% 4/292 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Platelet count decreased	1.8% 15/851 • Number of events 19 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.4% 10/294 • Number of events 11 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.94% 8/851 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 8/294 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.1% 9/292 • Number of events 14 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.24% 2/851 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 8/294 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.1% 6/292 • Number of events 8 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Neuropathy peripheral	14.1% 120/851 • Number of events 130 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.4% 7/294 • Number of events 7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.1% 6/292 • Number of events 7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Paraesthesia	7.1% 60/851 • Number of events 65 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.7% 5/294 • Number of events 7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.1% 6/292 • Number of events 6 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Nervous system disorders Peripheral sensory neuropathy	7.3% 62/851 • Number of events 65 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.7% 5/292 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Psychiatric disorders Insomnia	5.1% 43/851 • Number of events 44 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.4% 10/294 • Number of events 14 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	2.7% 8/292 • Number of events 9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.3% 11/851 • Number of events 11 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.7% 5/294 • Number of events 6 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.68% 2/292 • Number of events 2 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/851 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.1% 1/9 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Alopecia	32.8% 279/851 • Number of events 279 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.34% 1/294 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.7% 5/292 • Number of events 5 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/7 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Thrombosis	0.12% 1/851 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/294 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/292 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	14.3% 1/7 • Number of events 1 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/9 • Up to approximately 4 years Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

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

Restriction type: OTHER