Trial Outcomes & Findings for Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003) (NCT NCT04738487)

NCT ID: NCT04738487

Last Updated: 2025-08-26

Results Overview

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

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1264 participants
• Primary outcome timeframe: Up to ~39 months
• Results posted on: 2025-08-26

Participant Flow

Final analysis for the reported results, including participant flow, was performed on 1206 participants enrolled within the primary completion data cutoff. Analysis of the remaining 58 participants will be included in the End of Trial analysis. Per protocol, response/progression or adverse events that occurred during second course were not included in efficacy or safety outcome measures.

Participant milestones

Measure	Pembrolizumab/Vibostolimab Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).	Pembrolizumab Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).
Overall Study STARTED	594	612
Overall Study Treated	593	610
Overall Study Received Pembrolizumab/Vibostolimab (MK-7684A) Second Course	1	0
Overall Study Received Pembrolizumab Second Course	0	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	594	612

Reasons for withdrawal

Measure	Pembrolizumab/Vibostolimab Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).	Pembrolizumab Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).
Overall Study Participant Ongoing in Study	298	297
Overall Study Withdrawal by Subject	7	9
Overall Study Lost to Follow-up	2	0
Overall Study Death	287	306

Baseline Characteristics

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

Baseline characteristics by cohort

Measure	Pembrolizumab/Vibostolimab n=594 Participants Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).	Pembrolizumab n=612 Participants Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).	Total n=1206 Participants Total of all reporting groups
Age, Continuous	66.5 Years STANDARD_DEVIATION 9.8 • n=5 Participants	66.3 Years STANDARD_DEVIATION 10.2 • n=7 Participants	66.4 Years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants	172 Participants n=7 Participants	349 Participants n=5 Participants
Sex: Female, Male Male	417 Participants n=5 Participants	440 Participants n=7 Participants	857 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	152 Participants n=5 Participants	132 Participants n=7 Participants	284 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	434 Participants n=5 Participants	471 Participants n=7 Participants	905 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) Asian	247 Participants n=5 Participants	271 Participants n=7 Participants	518 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	291 Participants n=5 Participants	288 Participants n=7 Participants	579 Participants n=5 Participants
Race (NIH/OMB) More than one race	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0	165 Participants n=5 Participants	163 Participants n=7 Participants	328 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1	429 Participants n=5 Participants	448 Participants n=7 Participants	877 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 2	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS ≥ 50%	272 Participants n=5 Participants	307 Participants n=7 Participants	579 Participants n=5 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS 1-49%	322 Participants n=5 Participants	305 Participants n=7 Participants	627 Participants n=5 Participants
Geographic Region East Asia	239 Participants n=5 Participants	260 Participants n=7 Participants	499 Participants n=5 Participants
Geographic Region Non-East Asia	355 Participants n=5 Participants	352 Participants n=7 Participants	707 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to ~39 months

Population: The analysis population consisted of all participants with PD-L1 TPS ≥ 50% who were randomized prior to the primary completion data cut-off.

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

Outcome measures

Measure	Pembrolizumab/Vibostolimab n=272 Participants Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Pembrolizumab n=307 Participants Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Overall Survival (OS) in Participants With PD-L1 TPS ≥50%	15.7 Months Interval 12.4 to 24.0	20.3 Months Interval 16.7 to 24.2

SECONDARY outcome

Timeframe: Up to ~39 months

Population: The analysis population consisted of all participants with PD-L1 TPS ≥ 1% who were randomized prior to the primary completion data cut-off.

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

Outcome measures

Measure	Pembrolizumab/Vibostolimab n=594 Participants Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Pembrolizumab n=612 Participants Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
OS in Participants With PD-L1 TPS ≥1%	15.0 Months Interval 12.7 to 17.4	16.4 Months Interval 14.9 to 19.1

SECONDARY outcome

Timeframe: Up to ~39 months

Population: The analysis population consisted of all participants with PD-L1 TPS 1% to 49% who were randomized prior to the primary completion data cut-off.

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

Outcome measures

Measure	Pembrolizumab/Vibostolimab n=322 Participants Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Pembrolizumab n=305 Participants Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
OS in Participants With PD-L1 TPS 1% to 49%	14.3 Months Interval 11.3 to 17.8	14.3 Months Interval 11.7 to 16.1

SECONDARY outcome

Timeframe: Up to ~56 months

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to ~56 months

TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~56 months

The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab First Course

Serious events: 220 serious events

Other events: 472 other events

Deaths: 310 deaths

Pembrolizumab/Vibostolimab Second Course

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pembrolizumab Second Course

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Pembrolizumab/Vibostolimab First Course

Serious events: 249 serious events

Other events: 478 other events

Deaths: 291 deaths

Serious adverse events

Measure	Pembrolizumab First Course n=610 participants at risk Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Pembrolizumab/Vibostolimab Second Course n=1 participants at risk Participants who stopped pembrolizumab/vibostolimab after receiving 35 treatment cycles or participants who stopped pembrolizumab/vibostolimab after attaining a confirmed CR were eligible for a second course of pembrolizumab/vibostolimab. Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by IV infusion Q3W for up to 17 additional administrations.	Pembrolizumab Second Course n=3 participants at risk Participants who stopped pembrolizumab after receiving 35 treatment cycles or participants who stopped pembrolizumab after attaining a confirmed CR were eligible for a second course of pembrolizumab. Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 17 additional administrations.	Pembrolizumab/Vibostolimab First Course n=593 participants at risk Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	0.98% 6/610 • Number of events 6 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Blood and lymphatic system disorders Leukopenia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Acute coronary syndrome	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Acute myocardial infarction	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Atrial fibrillation	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Cardiac arrest	0.66% 4/610 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Cardiac failure	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Cardiac failure acute	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Cardiac tamponade	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Coronary artery disease	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Dilated cardiomyopathy	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Immune-mediated myocarditis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Left ventricular dysfunction	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Myocardial infarction	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Myocardial injury	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Myocarditis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Nodal rhythm	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Pericardial effusion	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	1.0% 6/593 • Number of events 6 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Stress cardiomyopathy	0.33% 2/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Cardiac disorders Supraventricular tachycardia	0.33% 2/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Adrenal insufficiency	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Glucocorticoid deficiency	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Hypophysitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Thyroid mass	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Eye disorders Blindness	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Eye disorders Cataract	0.33% 2/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Eye disorders Diabetic retinopathy	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Eye disorders Uveitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pulmonary sepsis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Abdominal pain upper	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Colitis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Constipation	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Dysphagia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Enterocolitis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Flatulence	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Gastric ulcer	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Gastritis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Immune-mediated enterocolitis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Immune-mediated pancreatitis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Intestinal fistula	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Intestinal obstruction	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Intestinal perforation	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Intestinal ulcer	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Melaena	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Nausea	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Pancreatitis	0.66% 4/610 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Pancreatitis acute	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Retroperitoneal mass	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Small intestinal ulcer haemorrhage	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Vomiting	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Asthenia	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Chest discomfort	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Chest pain	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Death	1.6% 10/610 • Number of events 10 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.84% 5/593 • Number of events 5 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Fatigue	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Influenza like illness	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Malaise	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Mucosal inflammation	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Multiple organ dysfunction syndrome	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Pain	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Pyrexia	0.49% 3/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Sudden death	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Cholecystitis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Drug-induced liver injury	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Hepatic failure	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Hepatitis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Hepatitis acute	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Hepatotoxicity	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Hepatobiliary disorders Immune-mediated hepatitis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Immune system disorders Cytokine release syndrome	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Immune system disorders Hypersensitivity	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Abdominal sepsis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Abscess limb	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Anal abscess	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Appendicitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Appendicitis perforated	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Bronchitis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations COVID-19	0.98% 6/610 • Number of events 6 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	1.3% 8/593 • Number of events 8 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations COVID-19 pneumonia	0.98% 6/610 • Number of events 6 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Cellulitis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Chlamydial infection	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Cytomegalovirus gastritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Cytomegalovirus infection	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Device related infection	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Diarrhoea infectious	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Empyema	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Encephalitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Endocarditis bacterial	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Enterocolitis infectious	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Gastroenteritis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Herpes zoster	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Infected dermal cyst	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Infectious pleural effusion	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Klebsiella sepsis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Lung abscess	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Meningitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Meningitis viral	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Mycoplasma infection	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Orchitis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pneumonia	9.2% 56/610 • Number of events 60 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	9.6% 57/593 • Number of events 66 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pneumonia aspiration	0.16% 1/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pneumonia influenzal	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pneumonia viral	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Postoperative wound infection	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pyelonephritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Respiratory tract infection	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Sepsis	1.1% 7/610 • Number of events 7 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Septic shock	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Urinary tract infection	1.3% 8/610 • Number of events 8 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	1.7% 10/593 • Number of events 12 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Urosepsis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Compression fracture	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Contusion	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Femur fracture	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Fracture	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Hip fracture	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Snake bite	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Alanine aminotransferase increased	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Aspartate aminotransferase increased	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Blood bilirubin increased	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Blood creatine phosphokinase increased	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Blood creatinine increased	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Hepatic enzyme abnormal	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Lipase increased	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Platelet count decreased	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations White blood cell count decreased	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Cachexia	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Decreased appetite	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Dehydration	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Gout	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hypokalaemia	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hyponatraemia	0.66% 4/610 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Bone callus excessive	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Immune-mediated arthritis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.16% 1/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Brain oedema	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Cerebral infarction	0.49% 3/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Cerebral ischaemia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Cerebral microinfarction	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Cerebrovascular accident	0.82% 5/610 • Number of events 6 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.67% 4/593 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Dizziness	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Encephalitis autoimmune	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Epilepsy	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Haemorrhage intracranial	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Headache	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Hypoaesthesia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Hypoglycaemic coma	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Immune-mediated encephalitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Immune-mediated myelitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Ischaemic stroke	0.49% 3/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Lacunar infarction	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Myasthenia gravis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Nerve compression	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Neuralgia	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Neuritis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Optic neuritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Seizure	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Nervous system disorders Syncope	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Psychiatric disorders Anxiety	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Psychiatric disorders Delirium	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Renal and urinary disorders Acute kidney injury	0.66% 4/610 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Renal and urinary disorders Immune-mediated cystitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Renal and urinary disorders Nephritis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Renal and urinary disorders Renal failure	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Renal and urinary disorders Tubulointerstitial nephritis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Renal and urinary disorders Urinary retention	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Bronchus compression	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.98% 6/610 • Number of events 7 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	1.7% 10/593 • Number of events 10 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.49% 3/610 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.66% 4/610 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 12/610 • Number of events 14 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	2.2% 13/593 • Number of events 15 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.3% 8/610 • Number of events 8 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	2.4% 14/593 • Number of events 14 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 8/610 • Number of events 8 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	1.2% 7/593 • Number of events 7 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.66% 4/610 • Number of events 4 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	1.2% 7/593 • Number of events 7 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.51% 3/593 • Number of events 3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders SJS-TEN overlap	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Surgical and medical procedures Medical aid in dying	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.34% 2/593 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Deep vein thrombosis	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Embolism	0.33% 2/610 • Number of events 2 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Hypertension	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Hypotension	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Pelvic venous thrombosis	0.00% 0/610 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Peripheral arterial occlusive disease	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.17% 1/593 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Superior vena cava syndrome	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Venous thrombosis limb	0.16% 1/610 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/593 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.

Other adverse events

Measure	Pembrolizumab First Course n=610 participants at risk Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.	Pembrolizumab/Vibostolimab Second Course n=1 participants at risk Participants who stopped pembrolizumab/vibostolimab after receiving 35 treatment cycles or participants who stopped pembrolizumab/vibostolimab after attaining a confirmed CR were eligible for a second course of pembrolizumab/vibostolimab. Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by IV infusion Q3W for up to 17 additional administrations.	Pembrolizumab Second Course n=3 participants at risk Participants who stopped pembrolizumab after receiving 35 treatment cycles or participants who stopped pembrolizumab after attaining a confirmed CR were eligible for a second course of pembrolizumab. Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 17 additional administrations.	Pembrolizumab/Vibostolimab First Course n=593 participants at risk Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	19.2% 117/610 • Number of events 162 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	24.5% 145/593 • Number of events 182 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Hyperthyroidism	4.8% 29/610 • Number of events 32 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	6.6% 39/593 • Number of events 50 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Endocrine disorders Hypothyroidism	11.0% 67/610 • Number of events 78 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	9.4% 56/593 • Number of events 74 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Constipation	9.7% 59/610 • Number of events 66 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	11.0% 65/593 • Number of events 76 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Diarrhoea	9.7% 59/610 • Number of events 84 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	8.6% 51/593 • Number of events 68 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Nausea	7.4% 45/610 • Number of events 48 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	11.3% 67/593 • Number of events 81 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Gastrointestinal disorders Vomiting	3.3% 20/610 • Number of events 24 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.1% 30/593 • Number of events 33 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Fatigue	10.2% 62/610 • Number of events 69 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	10.3% 61/593 • Number of events 70 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
General disorders Pyrexia	6.2% 38/610 • Number of events 40 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	9.9% 59/593 • Number of events 69 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations COVID-19	8.4% 51/610 • Number of events 54 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	8.8% 52/593 • Number of events 58 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Pneumonia	5.7% 35/610 • Number of events 36 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.7% 34/593 • Number of events 37 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Upper respiratory tract infection	6.4% 39/610 • Number of events 51 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	2.9% 17/593 • Number of events 18 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Infections and infestations Urinary tract infection	4.4% 27/610 • Number of events 35 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.4% 32/593 • Number of events 36 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Alanine aminotransferase increased	11.8% 72/610 • Number of events 100 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	12.3% 73/593 • Number of events 98 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Amylase increased	7.0% 43/610 • Number of events 56 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	7.8% 46/593 • Number of events 76 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Aspartate aminotransferase increased	13.0% 79/610 • Number of events 106 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	13.2% 78/593 • Number of events 96 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Blood alkaline phosphatase increased	5.2% 32/610 • Number of events 35 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	7.3% 43/593 • Number of events 58 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Blood creatinine increased	7.4% 45/610 • Number of events 54 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	4.7% 28/593 • Number of events 41 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Blood lactate dehydrogenase increased	3.8% 23/610 • Number of events 29 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.2% 31/593 • Number of events 49 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Lipase increased	6.1% 37/610 • Number of events 46 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	6.6% 39/593 • Number of events 59 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations Weight decreased	11.3% 69/610 • Number of events 77 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	12.1% 72/593 • Number of events 80 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Investigations White blood cell count decreased	1.5% 9/610 • Number of events 17 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	3.5% 21/593 • Number of events 31 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Decreased appetite	13.8% 84/610 • Number of events 93 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	12.5% 74/593 • Number of events 82 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hyperglycaemia	7.2% 44/610 • Number of events 67 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	7.4% 44/593 • Number of events 70 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	12.0% 73/610 • Number of events 98 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	11.6% 69/593 • Number of events 89 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hypokalaemia	4.6% 28/610 • Number of events 44 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.4% 32/593 • Number of events 45 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Metabolism and nutrition disorders Hyponatraemia	8.5% 52/610 • Number of events 67 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	8.8% 52/593 • Number of events 74 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 49/610 • Number of events 58 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	7.6% 45/593 • Number of events 53 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Musculoskeletal and connective tissue disorders Back pain	6.2% 38/610 • Number of events 41 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.9% 35/593 • Number of events 37 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Cough	11.3% 69/610 • Number of events 73 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	8.6% 51/593 • Number of events 54 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 53/610 • Number of events 57 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	7.4% 44/593 • Number of events 47 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.2% 32/610 • Number of events 35 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	2.9% 17/593 • Number of events 20 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Dermatitis	2.3% 14/610 • Number of events 15 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	6.4% 38/593 • Number of events 45 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Pruritus	9.3% 57/610 • Number of events 69 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	17.9% 106/593 • Number of events 128 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Skin and subcutaneous tissue disorders Rash	8.7% 53/610 • Number of events 78 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	15.5% 92/593 • Number of events 116 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.
Vascular disorders Hypertension	3.3% 20/610 • Number of events 31 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/1 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	0.00% 0/3 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.	5.2% 31/593 • Number of events 36 • Up to approximately 39 months Serious \& Other AEs include participants randomized by primary completion data cutoff who received ≥1 dose of study drug. All-Cause Mortality (ACM) includes participants randomized by primary completion data cutoff. Progression of cancer was not deemed an AE unless related to study treatment. MedDRA terms "Neoplasm progression" "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM \& AEs reported separately for second course treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER