Trial Outcomes & Findings for A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) (NCT NCT04447755)

NCT ID: NCT04447755

Last Updated: 2025-10-03

Results Overview

ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 127 participants
• Primary outcome timeframe: Up to 16 weeks
• Results posted on: 2025-10-03

Participant Flow

Participants were recruited to tumor cohorts of Ewing Sarcoma, Rhabdomyosarcoma, High Grade Glioma, and Other Solid Tumors Excluding Osteosarcoma. Enrollment to the protocol pre-specified tumor cohort of "Other Solid Tumors Excluding Osteosarcoma" was further expanded into categories of Diffuse midline glioma, Medulloblastoma, and Ependymoma.

Participant milestones

Measure	Ewing Sarcoma Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Overall Study STARTED	9	17	8	9	9	9	66
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	9	17	8	9	9	9	66

Reasons for withdrawal

Measure	Ewing Sarcoma Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Overall Study Death	9	16	8	9	8	9	55
Overall Study Withdrawal by Parent/Guardian	0	1	0	0	0	0	0
Overall Study Sponsor Decision	0	0	0	0	1	0	10
Overall Study Lost to Follow-up	0	0	0	0	0	0	1

Baseline Characteristics

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)

Baseline characteristics by cohort

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=8 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=66 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Total n=127 Participants Total of all reporting groups
Age, Continuous	14.8 Years STANDARD_DEVIATION 4.0 • n=5 Participants	13.1 Years STANDARD_DEVIATION 4.7 • n=7 Participants	14.0 Years STANDARD_DEVIATION 3.1 • n=5 Participants	10.0 Years STANDARD_DEVIATION 5.2 • n=4 Participants	13.2 Years STANDARD_DEVIATION 4.5 • n=21 Participants	8.7 Years STANDARD_DEVIATION 5.7 • n=8 Participants	13.1 Years STANDARD_DEVIATION 5.6 • n=8 Participants	12.7 Years STANDARD_DEVIATION 5.3 • n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	32 Participants n=8 Participants	60 Participants n=24 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	34 Participants n=8 Participants	67 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants	13 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	43 Participants n=8 Participants	77 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	14 Participants n=8 Participants	37 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	13 Participants n=8 Participants	22 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants	35 Participants n=8 Participants	63 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	11 Participants n=8 Participants	32 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=6 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=65 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment	22.2 Percentage of Participants Interval 2.8 to 60.0	11.8 Percentage of Participants Interval 1.5 to 36.4	0.0 Percentage of Participants Interval 0.0 to 45.9	0.0 Percentage of Participants Interval 0.0 to 33.6	0.0 Percentage of Participants Interval 0.0 to 33.6	0.0 Percentage of Participants Interval 0.0 to 33.6	7.7 Percentage of Participants Interval 2.5 to 17.0

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

ORR was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response was assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=6 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=65 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment	22.2 Percentage of Participants Interval 2.8 to 60.0	11.8 Percentage of Participants Interval 1.5 to 36.4	0.0 Percentage of Participants Interval 0.0 to 45.9	0.0 Percentage of Participants Interval 0.0 to 33.6	0.0 Percentage of Participants Interval 0.0 to 33.6	0.0 Percentage of Participants Interval 0.0 to 33.6	7.7 Percentage of Participants Interval 2.5 to 17.0

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=6 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=65 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment	3.0 Months Interval 0.3 to 9.3	2.6 Months Interval 1.2 to 5.6	1.9 Months Interval 1.4 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	1.8 Months Interval 0.5 to 4.9	3.4 Months Interval 0.5 to 8.5	2.5 Months Interval 1.2 to 7.4	3.8 Months Interval 3.2 to 5.7

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=6 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=65 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment	22.2 Percentage of Participants Interval 2.8 to 60.0	11.8 Percentage of Participants Interval 1.5 to 36.4	0.0 Percentage of Participants Interval 0.0 to 45.9	0.0 Percentage of Participants Interval 0.0 to 33.6	0.0 Percentage of Participants Interval 0.0 to 33.6	0.0 Percentage of Participants Interval 0.0 to 33.6	7.7 Percentage of Participants Interval 2.5 to 17.0

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease, and demonstrated CR or PR.

DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.

Outcome measures

Measure	Ewing Sarcoma n=2 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=2 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=5 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment	NA Months Interval 5.7 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	4.6 Months Interval 3.7 to NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	—	—	—	—	4.6 Months Interval 3.7 to NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

DCR was defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=6 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=65 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment	66.7 Percentage of Participants Interval 29.9 to 92.5	52.9 Percentage of Participants Interval 27.8 to 77.0	33.3 Percentage of Participants Interval 4.3 to 77.7	22.2 Percentage of Participants Interval 2.8 to 60.0	55.6 Percentage of Participants Interval 21.2 to 86.3	55.6 Percentage of Participants Interval 21.2 to 86.3	64.6 Percentage of Participants Interval 51.8 to 76.1

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease.

CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=6 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=65 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment	33.3 Percentage of Participants Interval 7.5 to 70.1	29.4 Percentage of Participants Interval 10.3 to 56.0	0.0 Percentage of Participants Interval 0.0 to 45.9	11.1 Percentage of Participants Interval 0.3 to 48.2	44.4 Percentage of Participants Interval 13.7 to 78.8	33.3 Percentage of Participants Interval 7.5 to 70.1	40.0 Percentage of Participants Interval 28.0 to 52.9

SECONDARY outcome

Timeframe: Up to approximately 50 months

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

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

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=8 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=66 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Number of Participants Who Experienced an Adverse Event (AE)	9 Participants	17 Participants	8 Participants	9 Participants	9 Participants	8 Participants	66 Participants

SECONDARY outcome

Timeframe: Up to approximately 38 months

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

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

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=8 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 Participants Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 Participants Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=66 Participants Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Number of Participants Who Discontinued Study Treatment Due to an AE	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (cycle = 28 days)

Population: Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.

A hedonic Visual Analog Scale (VAS) was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the supplemental Statistical Analysis Plan (sSAP), all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the taste category is presented.

Outcome measures

Measure	Ewing Sarcoma n=10 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Really Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Good	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Super Bad	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Bad	2 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Maybe Good or Maybe Bad	5 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Really Good	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category Super Good	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (cycle = 28 days)

Population: Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.

A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the appearance category is presented.

Outcome measures

Measure	Ewing Sarcoma n=10 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Super Good	2 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Super Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Really Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Bad	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Maybe Good or Maybe Bad	5 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Good	2 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category Really Good	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (cycle = 28 days)

Population: Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.

A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the smell category is presented.

Outcome measures

Measure	Ewing Sarcoma n=10 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Super Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Super Good	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Really Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Maybe Good or Maybe Bad	8 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Good	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category Really Good	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (cycle = 28 days)

Population: Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.

A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the mouth feel category is presented.

Outcome measures

Measure	Ewing Sarcoma n=10 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Really Bad	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Bad	2 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Maybe Good or Maybe Bad	4 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Good	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Really Good	2 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Super Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category Super Good	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (cycle = 28 days)

Population: Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type.

A hedonic VAS was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the sSAP, all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the overall acceptability category is presented.

Outcome measures

Measure	Ewing Sarcoma n=10 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Really Bad	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Bad	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Good	3 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Really Good	1 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Super Bad	0 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Maybe Good or Maybe Bad	3 Participants	—	—	—	—	—	—
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category Super Good	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.

Population: All participants who received at least one dose of study treatment and had at least one measurable postdose plasma concentration with an adequately documented dosing history were analyzed. Lenvatinib exposures are reported by the four protocol pre-specified cohorts at the time of enrollment (EWS, RMS, HGG, and Other Solid Tumors excluding Osteosarcoma). For the purposes of the analysis, AUCss was reported for participants with "Other Solid Tumors" irrespective of tumor type.

Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.

Outcome measures

Measure	Ewing Sarcoma n=9 Participants Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 Participants Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=8 Participants Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=91 Participants Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)	5896 ng*hr/ml Geometric Coefficient of Variation 31.2	3915 ng*hr/ml Geometric Coefficient of Variation 32.9	3660 ng*hr/ml Geometric Coefficient of Variation 43.5	4990 ng*hr/ml Geometric Coefficient of Variation 53.2	—	—	—

Adverse Events

Ewing Sarcoma

Serious events: 4 serious events

Other events: 9 other events

Deaths: 9 deaths

Rhabdomyosarcoma

Serious events: 5 serious events

Other events: 17 other events

Deaths: 17 deaths

High Grade Glioma

Serious events: 6 serious events

Other events: 6 other events

Deaths: 8 deaths

Diffuse Midline Glioma

Serious events: 4 serious events

Other events: 9 other events

Deaths: 9 deaths

Medulloblastoma

Serious events: 4 serious events

Other events: 9 other events

Deaths: 8 deaths

Ependymoma

Serious events: 4 serious events

Other events: 7 other events

Deaths: 9 deaths

Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma

Serious events: 39 serious events

Other events: 66 other events

Deaths: 55 deaths

Serious adverse events

Measure	Ewing Sarcoma n=9 participants at risk Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 participants at risk Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=8 participants at risk Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 participants at risk Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 participants at risk Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 participants at risk Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=66 participants at risk Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Orbital compartment syndrome	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Anal fistula	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Duodenal perforation	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Enteritis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Enterocolitis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 haemorrhagic	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 obstruction	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Pneumoperitoneum	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Complication associated with device	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Bronchopulmonary aspergillosis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 sepsis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Gastroenteritis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Accidental overdose	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Ligament sprain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Overdose	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Pneumothorax traumatic	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Wound dehiscence	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 bilirubin increased	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Arthritis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Depressed level of consciousness	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hemiparesis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hydrocephalus	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Intracranial pressure increased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Posterior reversible encephalopathy syndrome	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Product Issues Device dislocation	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hallucination	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Neurogenic bladder	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Laryngeal fistula	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 11 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypertension	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	Ewing Sarcoma n=9 participants at risk Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.	Rhabdomyosarcoma n=17 participants at risk Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	High Grade Glioma n=8 participants at risk Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Diffuse Midline Glioma n=9 participants at risk Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Medulloblastoma n=9 participants at risk Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Ependymoma n=9 participants at risk Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.	Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma n=66 participants at risk Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	19.7% 13/66 • Number of events 15 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 13 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 dysfunction	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Palpitations	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Sinus bradycardia	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Sinus tachycardia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Ear and labyrinth disorders Ear pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Ear and labyrinth disorders Vertigo	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	77.8% 7/9 • Number of events 8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	47.1% 8/17 • Number of events 8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	50.0% 4/8 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	77.8% 7/9 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	77.8% 7/9 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	55.6% 5/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	68.2% 45/66 • Number of events 47 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Corneal erosion	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Dry eye	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Eyelid ptosis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Keratitis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Lagophthalmos	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Ocular hyperaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Strabismus	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Visual impairment	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	35.3% 6/17 • Number of events 9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	21.2% 14/66 • Number of events 18 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Anal haemorrhage	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Anal inflammation	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Anal ulcer	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Cheilitis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/17 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	16.7% 11/66 • Number of events 12 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	55.6% 5/9 • Number of events 13 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	35.3% 6/17 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	44.4% 4/9 • Number of events 8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 22/66 • Number of events 41 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Dyspepsia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.1% 6/66 • Number of events 10 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Flatulence	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Glossodynia	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Haematochezia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Haemorrhoids	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	33.3% 3/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	19.7% 13/66 • Number of events 13 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Odynophagia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Oral disorder	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Oral pain	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Proctalgia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Salivary hypersecretion	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Gastrointestinal disorders Stomatitis	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Toothache	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	44.4% 4/9 • Number of events 8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	41.2% 7/17 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	44.4% 4/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	27.3% 18/66 • Number of events 27 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
General disorders Asthenia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Face oedema	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	55.6% 5/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	19.7% 13/66 • Number of events 14 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Feeling cold	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Gait disturbance	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Influenza like illness	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Localised oedema	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Non-cardiac chest pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Oedema peripheral	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 12 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Xerosis	11.1% 1/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Cholestasis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 cytolysis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Jaundice	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Asymptomatic bacteriuria	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.1% 6/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Folliculitis	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Lip infection	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Localised infection	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 herpes	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Otitis media	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Infections and infestations Pneumonia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Pyuria	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	44.4% 4/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Accidental overdose	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Contusion	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hand fracture	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Medication error	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Urethral injury	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Wound complication	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.7% 15/66 • Number of events 22 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Amylase increased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	33.3% 3/9 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	29.4% 5/17 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	19.7% 13/66 • Number of events 15 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 bilirubin increased	22.2% 2/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.1% 6/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 lactate dehydrogenase increased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 thyroid stimulating hormone increased	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/17 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 urea increased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Ejection fraction decreased	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Electrocardiogram T wave abnormal	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Gamma-glutamyltransferase increased	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Haemoglobin increased	11.1% 1/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Lipase increased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Lymphocyte count decreased	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations Neutrophil count decreased	11.1% 1/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	44.4% 4/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	21.2% 14/66 • Number of events 16 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Protein total decreased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Thyroxine free increased	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	28.8% 19/66 • Number of events 19 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Investigations White blood cell count decreased	11.1% 1/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.1% 6/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	55.6% 5/9 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	41.2% 7/17 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	27.3% 18/66 • Number of events 22 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hyperphosphataemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hyperuricaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypoalbuminaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypocalcaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypokalaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypomagnesaemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypophosphataemia	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.1% 8/66 • Number of events 10 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Arthritis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Bone pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 3/66 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Muscle spasms	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 13 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Synovial cyst	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Tendon disorder	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 exudation	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Aphasia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Ataxia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Coma	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Diplegia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Dysaesthesia	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Dysarthria	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/17 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hemiparesis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hemiplegia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hydrocephalus	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hyporeflexia	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypotonia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Intracranial pressure increased	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Lethargy	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Memory impairment	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Muscle spasticity	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Neuralgia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Neurological decompensation	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Petit mal epilepsy	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Quadriparesis	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Somnolence	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Speech disorder	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Taste disorder	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Bradyphrenia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Poor quality sleep	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Anuria	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Glycosuria	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Haematuria	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	3.0% 2/66 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Renal and urinary disorders Proteinuria	22.2% 2/9 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	29.4% 5/17 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	42.4% 28/66 • Number of events 38 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Urinary incontinence	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Urinary retention	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Breast induration	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	33.3% 3/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	22.2% 2/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	17.6% 3/17 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	13.6% 9/66 • Number of events 10 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hypoxia	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Oropharyngeal pain	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Acne	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 4/66 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Blister	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 exfoliative generalised	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Dry skin	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	9.1% 6/66 • Number of events 6 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Erythema	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hair colour changes	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	11.8% 2/17 • Number of events 2 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	7.6% 5/66 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Papule	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	44.4% 4/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	10.6% 7/66 • Number of events 9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 erythematous	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Skin hyperpigmentation	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Skin induration	11.1% 1/9 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Skin irritation	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Urticaria	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Flushing	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/17 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	12.5% 1/8 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/66 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 Hot flush	0.00% 0/9 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	5.9% 1/17 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	0.00% 0/8 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study 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 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	1.5% 1/66 • Number of events 1 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
Vascular disorders Hypertension	33.3% 3/9 • Number of events 4 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	35.3% 6/17 • Number of events 7 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	25.0% 2/8 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	55.6% 5/9 • Number of events 5 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	33.3% 3/9 • Number of events 3 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.	40.9% 27/66 • Number of events 33 • Up to approximately 50 months The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered 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 The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER