Trial Outcomes & Findings for Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006) (NCT NCT03829319)

Last Updated: 2026-02-05

Results Overview

An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one of more adverse events during Part 1 of this study will be presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

761 participants

Primary outcome timeframe

Up to approximately 48 months

Results posted on

2026-02-05

Participant Flow

Participants with treatment-naïve, metastatic nonsquamous Non-small cell lung cancer (NSCLC) were recruited in this study.

Per protocol, Part 1 participants were excluded from all Part 2 efficacy and safety outcome measures. China participants randomized during the global study phase (134 participants) were included in all global study analyses. China participants randomized during the China extension phase were excluded from all global study analyses and were included in the China-specific analyses in the extension study (NCT04716933).

Participant milestones

Participant milestones
Measure	Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Overall Study STARTED	13	375	373
Overall Study Treated During First Course	13	373	372
Overall Study Treated During Second Course	1	3	5
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	13	375	373

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Overall Study Lost to Follow-up	0	0	1
Overall Study Death	8	277	266
Overall Study Sponsor's Decision	4	90	102
Overall Study Withdrawal by Subject	1	5	4
Overall Study Physician Decision	0	3	0

Baseline Characteristics

Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=13 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=375 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=373 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.	Total n=761 Participants Total of all reporting groups
Age, Continuous	64.2 Years STANDARD_DEVIATION 7.6 • n=25 Participants	62.0 Years STANDARD_DEVIATION 9.9 • n=26 Participants	63.0 Years STANDARD_DEVIATION 9.7 • n=51 Participants	62.5 Years STANDARD_DEVIATION 9.8 • n=27 Participants
Sex: Female, Male Female	6 Participants n=25 Participants	121 Participants n=26 Participants	126 Participants n=51 Participants	253 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=25 Participants	254 Participants n=26 Participants	247 Participants n=51 Participants	508 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=25 Participants	75 Participants n=26 Participants	77 Participants n=51 Participants	152 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=25 Participants	291 Participants n=26 Participants	279 Participants n=51 Participants	583 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	9 Participants n=26 Participants	17 Participants n=51 Participants	26 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=25 Participants	116 Participants n=26 Participants	114 Participants n=51 Participants	235 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	2 Participants n=26 Participants	1 Participants n=51 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants	0 Participants n=26 Participants	3 Participants n=51 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	8 Participants n=25 Participants	248 Participants n=26 Participants	237 Participants n=51 Participants	493 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	9 Participants n=26 Participants	17 Participants n=51 Participants	26 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0	8 Participants n=25 Participants	135 Participants n=26 Participants	133 Participants n=51 Participants	276 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1	5 Participants n=25 Participants	240 Participants n=26 Participants	240 Participants n=51 Participants	485 Participants n=27 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS = < 50%	10 Participants n=25 Participants	272 Participants n=26 Participants	269 Participants n=51 Participants	551 Participants n=27 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS = ≥ 50%	3 Participants n=25 Participants	90 Participants n=26 Participants	91 Participants n=51 Participants	184 Participants n=27 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline Not Evaluable	0 Participants n=25 Participants	13 Participants n=26 Participants	13 Participants n=51 Participants	26 Participants n=27 Participants
Geographic Region East Asia	3 Participants n=25 Participants	111 Participants n=26 Participants	112 Participants n=51 Participants	226 Participants n=27 Participants
Geographic Region Non-East Asia	10 Participants n=25 Participants	264 Participants n=26 Participants	261 Participants n=51 Participants	535 Participants n=27 Participants

PRIMARY outcome

Timeframe: Cycle 1; each cycle is 21 days (up to 21 days)

Population: The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention.

Dose-limiting toxicity using Common Terminology Criteria for Adverse Events v4.0 for grading, is defined as any of the following hematologic toxicities: 1) Grade 4 neutropenia, 2) Grade 3 or 4 febrile neutropenia, 3) thrombocytopenia \<25,000 cells/mm\^3 associated with bleeding and/or which requires platelet transfusion, or any of the following non-hematologic toxicities: 4) any other Grade 4 or 5 toxicity, 5) Grade 3 toxicities lasting \>3 days (exclusions apply), 6) Grade 3 hypertension not controlled by medication, 7) Grade 3 or above gastrointestinal perforation, 8) Grade 3 or above wound dehiscence requiring medical or surgical intervention, 9) any grade thromboembolic event, or 10) any Grade 3 nonhematologic laboratory value if medical intervention is required or the abnormality leads to hospitalization.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=13 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 1: Number of Participants With a Dose-limiting Toxicity (DLT)	2 Participants	—

PRIMARY outcome

Timeframe: Up to approximately 48 months

Population: The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=13 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 1: Number of Participants Who Experienced an Adverse Event (AE)	13 Participants	—

PRIMARY outcome

Timeframe: Up to approximately 58 months

Population: The analysis population consisted of all participants enrolled in Part 1 who received at least 1 dose of study intervention.

An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study medication due to and adverse event during Part 1 of this study will be presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=13 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 1: Number of Participants Who Discontinued Study Drug Due to an Adverse Event	9 Participants	—

PRIMARY outcome

Timeframe: Up to approximately 36 months

Population: The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.

PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=375 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=373 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	12.1 Months Interval 10.4 to 14.1	9.5 Months Interval 8.3 to 10.7

PRIMARY outcome

Timeframe: Up to approximately 47 months

Population: The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.

OS is defined as the time from randomization to the time of death from any cause. OS is presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=375 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=373 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Overall Survival (OS)	21.8 Months Interval 18.6 to 24.0	22.1 Months Interval 19.7 to 24.2

SECONDARY outcome

Timeframe: Up to approximately 19 months

Population: The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.

ORR is defined as the percentage of participants in the analysis population 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 RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR as assessed per modified RECIST 1.1 will be presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=212 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=211 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	57.1 Percentage of Participants Interval 50.1 to 63.8	50.7 Percentage of Participants Interval 43.8 to 57.6

SECONDARY outcome

Timeframe: Up to approximately 48 months

Population: The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention and were evaluable for response.

For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, 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. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed per modified RECIST 1.1 will be presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=375 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=373 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	1.6 Months Interval 1.1 to 15.4	1.6 Months Interval 1.2 to 20.7

SECONDARY outcome

Timeframe: Up to approximately 58 months

Population: The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention.

An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one of more adverse events during Part 2 of this study were presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=373 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=372 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Number of Participants Who Experienced an Adverse Event (AE)	372 Participants	370 Participants

SECONDARY outcome

Timeframe: Up to approximately 58 months

Population: The analysis population consisted of all randomized participants in Part 2 who received at least 1 dose of study intervention.

An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment during Part 2 of this study were presented.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=373 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=372 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event	127 Participants	92 Participants

SECONDARY outcome

Timeframe: Baseline and Week 27

Population: The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 29 and 30 assessment data available.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are each scored on a 7-point scale (1=Very poor to 7=Excellent). The two raw scores were averaged into a combined score, then normalized using linear transformation so each participant's score ranged from 0 to 100 (0=Worst overall health/quality of life and 100=Best overall health/quality of life). The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=369 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=371 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Items 29 and 30) Score	0.65 Score on a Scale Interval -1.55 to 2.84	1.66 Score on a Scale Interval -0.53 to 3.85

SECONDARY outcome

Timeframe: Baseline and week 27

The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=368 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=371 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score	-11.77 Score on a scale Interval -14.72 to -8.81	-11.47 Score on a scale Interval -14.42 to -8.53

SECONDARY outcome

Timeframe: Baseline and Week 27

The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=368 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=371 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score	-4.61 Score on a scale Interval -7.26 to -1.96	-3.70 Score on a scale Interval -6.34 to -1.06

SECONDARY outcome

Timeframe: Baseline and Week 27

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=369 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=371 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score	-2.77 Score on a scale Interval -6.04 to 0.5	-0.61 Score on a scale Interval -3.86 to 2.65

SECONDARY outcome

Timeframe: Baseline and Week 27

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=369 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=371 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score	-4.11 Score on a scale Interval -6.37 to -1.84	-3.73 Score on a scale Interval -5.99 to -1.48

SECONDARY outcome

Timeframe: Baseline and Week 27

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS/QoL (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS/QoL score, will be presented. A longer TTD indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=358 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=357 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/Quality of Life (QoL) (EORTC QLQ-C30 Items 29 and 30) Score	15.70 Months Interval 9.66 to NA=Upper range time to deterioration was not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.	NA Months Interval 21.32 to NA=Median and upper range time to deterioration was not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.

SECONDARY outcome

Timeframe: Baseline And Week 27

Population: The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-LC30 Item 31 assessment data available at baseline.

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline cough (EORTC QLQ-LC30 Items 31) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=356 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=353 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: TTD Based on Change From Baseline in Cough EORTC QLQ-LC13 (Item 31) Score	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.

SECONDARY outcome

Timeframe: Baseline and Week 27

Population: The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC QLQ-LC13 chest pain Item 40 Score assessment data available at baseline.

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline chest pain (EORTC QLQ-C30 Item 40) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in chest pains core, will be presented. A longer TTD indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=356 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=353 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: TTD Based on Change From Baseline in Chest Pain EORTC QLQ-LC13 (Item 40) Score	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.

SECONDARY outcome

Timeframe: Baseline and Week 27

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline dyspnea (EORTC QLQ-C30 Item 8) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=358 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=357 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: TTD Based on Change From Baseline in Dyspnea EORTC QLQ-C30 (Item 8) Score	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.

SECONDARY outcome

Timeframe: Baseline and Week 27

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline physical functioning (EORTC QLQ-C30 Items 1 through 5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=358 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=357 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: TTD Based on Change From Baseline in Physical Functioning EORTC QLQ-C30 (Items 1 Through 5) Score	16.82 Months Interval 8.84 to 22.51	NA Months NA=Median, lower and upper range time to deterioration were not reached at time of data cut-off due to insufficient number of participants experiencing deterioration.

SECONDARY outcome

Timeframe: Baseline and Week 27

Population: The analysis population consisted of all randomized participants in Part 2 who received at least one dose of study treatment and have at least one EORTC-QLQ-LC13 Items 31 and 40 and EORTC-QLQ-C30 Item 8 assessment data available.

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.

Outcome measures

Outcome measures
Measure	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=358 Participants Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=358 Participants Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.
Part 2: Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)	8.28 Months Interval 5.98 to 11.07	9.33 Months Interval 7.03 to 12.91

Adverse Events

Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib

Serious events: 7 serious events

Other events: 13 other events

Deaths: 9 deaths

Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib

Serious events: 232 serious events

Other events: 366 other events

Deaths: 278 deaths

Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo

Serious events: 189 serious events

Other events: 363 other events

Deaths: 266 deaths

Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2 Second Course: Pembrolizumab+Chemotherapy+Lenvatinib

Serious events: 1 serious events

Other events: 2 other events

Deaths: 3 deaths

Part 2 Second Course: Pembrolizumab+Chemotherapy+Placebo

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=13 participants at risk Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=373 participants at risk Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=372 participants at risk Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.	Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib n=1 participants at risk Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year, without chemotherapy plus lenvatinib.	Part 2 Second Course: Pembrolizumab+Chemotherapy+Lenvatinib n=3 participants at risk Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year. Participants previously receiving Lenvatinib could continue receiving lenvatinib at investigator's discretion.	Part 2 Second Course: Pembrolizumab+Chemotherapy+Placebo n=7 participants at risk Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year. Participants previously receiving placebo could continue receiving placebo at investigator's discretion.
Gastrointestinal disorders Pancreatitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Proctitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Subileus	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Vomiting	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Asthenia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Chest discomfort	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Chest pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Death	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Fatigue	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders General physical health deterioration	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Malaise	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Mucosal inflammation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Multiple organ dysfunction syndrome	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Non-cardiac chest pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Oedema	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Peripheral swelling	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Pyrexia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Sudden death	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Hepatic haematoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Hepatitis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Hepatobiliary disorders Perforation bile duct	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Immune system disorders Anaphylactic reaction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Immune system disorders Anaphylactic shock	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Abdominal sepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Anorectal infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Appendicitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Biliary sepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Bronchitis	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Bronchitis viral	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations COVID-19	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/372 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Catheter site infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Cellulitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Diverticulitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Encephalitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Erysipelas	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Febrile infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Gastroenteritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Herpes zoster	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Myelitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Neutropenic sepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Osteomyelitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Parainfluenzae virus infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Peritonsillar abscess	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.5% 28/373 • Number of events 37 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	9.7% 36/372 • Number of events 40 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia aspiration	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia bacterial	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia fungal	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia klebsiella	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pulmonary sepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pyelonephritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pyelonephritis acute	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Respiratory tract infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Sepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Septic shock	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Sinusitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Skin infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Tuberculosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Urinary tract infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Urosepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Varicella zoster virus infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Toxicity to various agents	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Alanine aminotransferase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Amylase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood creatinine increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Lipase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Lymphocyte count decreased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Neutrophil count decreased	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Platelet count decreased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.2% 8/372 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations SARS-CoV-2 test positive	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Weight decreased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations White blood cell count decreased	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Basal ganglia infarction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Brain oedema	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cerebral haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cerebral infarction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cerebral ischaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cerebral thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cognitive disorder	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Dysarthria	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Encephalopathy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Epilepsy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Haemorrhagic stroke	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Immune-mediated encephalopathy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Intracranial aneurysm	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Ischaemic stroke	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Lethargy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Seizure	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Sensory disturbance	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Spinal cord compression	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Spondylitic myelopathy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Syncope	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Product Issues Device dislocation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Behaviour disorder	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Completed suicide	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Confusional state	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Delirium	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Disorientation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Suicide attempt	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Autoimmune nephritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Immune-mediated nephritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Nephritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Nephropathy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Proteinuria	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Renal failure	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Renal impairment	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Reproductive system and breast disorders Prostatitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.8% 14/373 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/372 • Number of events 16 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.9% 11/373 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.2% 8/372 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Dermatitis herpetiformis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Pseudocellulitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Superficial inflammatory dermatosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Aortic aneurysm	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Arterial disorder	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Arterial thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Hypertension	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Hypotension	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Jugular vein thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Peripheral artery thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Superior vena cava syndrome	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Venous thrombosis limb	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Retinal detachment	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Ulcerative keratitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Soft tissue infection	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Suicidal ideation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Embolism	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.6% 17/373 • Number of events 19 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.2% 12/373 • Number of events 13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Angina pectoris	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Atrial thrombosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Atrial flutter	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Cardiac arrest	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Myocarditis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Cardiac tamponade	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Coronary artery disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Immune-mediated myocarditis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Myocardial infarction	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/373 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Pericardial effusion	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Ear and labyrinth disorders Vertigo positional	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Adrenal haematoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Adrenal insufficiency	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Hypophysitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Hypothyroidism	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Cataract	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Vitreous haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Anal fistula	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Ascites	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Coeliac artery stenosis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Duodenitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Enteritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Faecaloma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gastritis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Ileus	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Intestinal perforation	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Nausea	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Obstruction gastric	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Oral pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.

Other adverse events

Other adverse events
Measure	Part 1 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=13 participants at risk Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Lenvatinib n=373 participants at risk Participants received carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib 8 mg via oral capsule once daily.	Part 2 First Course: Pembrolizumab+Chemotherapy+Placebo n=372 participants at risk Participants received carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab 200 mg via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS placebo matching lenvatinib via oral capsule once daily.	Part 1 Second Course: Pembrolizumab Only From Pembrolizumab+Chemotherapy+Lenvatinib n=1 participants at risk Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year, without chemotherapy plus lenvatinib.	Part 2 Second Course: Pembrolizumab+Chemotherapy+Lenvatinib n=3 participants at risk Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year. Participants previously receiving Lenvatinib could continue receiving lenvatinib at investigator's discretion.	Part 2 Second Course: Pembrolizumab+Chemotherapy+Placebo n=7 participants at risk Qualified participants who completed the first course of pembrolizumab plus chemotherapy plus lenvatinib for up to 35 cycles (up to 2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q2W for up to \~1 year. Participants previously receiving placebo could continue receiving placebo at investigator's discretion.
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	51.5% 192/373 • Number of events 394 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	59.1% 220/372 • Number of events 419 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Adrenal insufficiency	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Hyperthyroidism	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.0% 26/373 • Number of events 30 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.2% 23/372 • Number of events 27 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Hypothyroidism	38.5% 5/13 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	22.5% 84/373 • Number of events 104 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	11.3% 42/372 • Number of events 46 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Endocrine disorders Thyroid mass	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Cataract	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Dry eye	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/373 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.8% 14/372 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Eye pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Eye pruritus	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Glaucoma	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Lacrimation increased	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.4% 24/373 • Number of events 25 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.5% 24/372 • Number of events 28 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Eye disorders Vision blurred	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.8% 33/373 • Number of events 47 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/372 • Number of events 27 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Nausea	76.9% 10/13 • Number of events 17 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	39.7% 148/373 • Number of events 264 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	36.8% 137/372 • Number of events 246 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.0% 30/373 • Number of events 33 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.8% 18/372 • Number of events 20 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Anal incontinence	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Constipation	53.8% 7/13 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	32.2% 120/373 • Number of events 169 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	29.6% 110/372 • Number of events 143 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Diarrhoea	53.8% 7/13 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	34.0% 127/373 • Number of events 245 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	18.5% 69/372 • Number of events 107 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	100.0% 1/1 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Dry mouth	23.1% 3/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/372 • Number of events 12 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Dyspepsia	23.1% 3/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.2% 23/373 • Number of events 25 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.0% 11/372 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.5% 13/373 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Flatulence	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gastrointestinal pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gingival bleeding	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Gingival pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.9% 11/373 • Number of events 15 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Glossodynia	7.7% 1/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Lip dry	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Oral pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/373 • Number of events 16 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Rectal ulcer	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Stomatitis	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	12.6% 47/373 • Number of events 64 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.6% 21/372 • Number of events 30 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Toothache	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.5% 13/373 • Number of events 17 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Gastrointestinal disorders Vomiting	38.5% 5/13 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	18.5% 69/373 • Number of events 133 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	16.7% 62/372 • Number of events 99 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Asthenia	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	29.0% 108/373 • Number of events 167 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	29.6% 110/372 • Number of events 175 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Chest pain	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.6% 21/373 • Number of events 23 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.7% 25/372 • Number of events 29 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Extravasation	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Fatigue	61.5% 8/13 • Number of events 15 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	31.1% 116/373 • Number of events 182 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	23.1% 86/372 • Number of events 114 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Gait disturbance	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders General physical health deterioration	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Influenza like illness	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Malaise	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/373 • Number of events 24 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/372 • Number of events 18 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Mucosal inflammation	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	12.6% 47/373 • Number of events 62 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.5% 28/372 • Number of events 35 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Non-cardiac chest pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Oedema	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Oedema peripheral	23.1% 3/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	16.4% 61/373 • Number of events 81 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	13.2% 49/372 • Number of events 70 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
General disorders Pyrexia	7.7% 1/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	15.3% 57/373 • Number of events 98 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	16.4% 61/372 • Number of events 83 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations COVID-19	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.6% 32/373 • Number of events 32 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.2% 23/372 • Number of events 24 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Conjunctivitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.4% 24/373 • Number of events 27 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.8% 18/372 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Sepsis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Device related infection	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Eye infection	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Fungal skin infection	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Gastroenteritis viral	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Herpes zoster	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/373 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Nasopharyngitis	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Oral candidiasis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/373 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Oral herpes	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Oral infection	7.7% 1/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Otitis externa	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.2% 23/373 • Number of events 27 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.6% 21/372 • Number of events 22 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Pneumonia bacterial	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Tooth infection	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Upper respiratory tract infection	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.9% 22/373 • Number of events 31 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/372 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Urinary tract infection	38.5% 5/13 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.0% 30/373 • Number of events 41 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.8% 29/372 • Number of events 35 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Viral pharyngitis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Contusion	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Fall	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Ligament injury	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Alanine aminotransferase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	35.4% 132/373 • Number of events 271 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	32.0% 119/372 • Number of events 251 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Amylase increased	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.7% 55/373 • Number of events 108 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.8% 55/372 • Number of events 95 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	34.0% 127/373 • Number of events 311 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	29.0% 108/372 • Number of events 240 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.3% 31/373 • Number of events 52 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.3% 31/372 • Number of events 44 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood bilirubin increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 31 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 18 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood creatinine increased	38.5% 5/13 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	17.7% 66/373 • Number of events 122 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	18.5% 69/372 • Number of events 104 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood glucose increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.6% 21/373 • Number of events 31 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.9% 22/372 • Number of events 28 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood magnesium decreased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.2% 23/373 • Number of events 31 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.6% 17/372 • Number of events 29 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	10.2% 38/373 • Number of events 51 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 12 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	13.1% 49/373 • Number of events 73 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.1% 30/372 • Number of events 39 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Lactescent serum	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Lipase increased	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	12.6% 47/373 • Number of events 94 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	11.6% 43/372 • Number of events 82 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Lymphocyte count decreased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.8% 29/373 • Number of events 54 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.8% 18/372 • Number of events 31 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Neutrophil count decreased	30.8% 4/13 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	50.4% 188/373 • Number of events 526 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	41.4% 154/372 • Number of events 436 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Platelet count decreased	7.7% 1/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	39.7% 148/373 • Number of events 348 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	26.3% 98/372 • Number of events 203 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations SARS-CoV-2 test positive	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Weight decreased	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	18.5% 69/373 • Number of events 82 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.8% 29/372 • Number of events 31 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Weight increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 30 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations White blood cell count decreased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	31.9% 119/373 • Number of events 372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	25.5% 95/372 • Number of events 306 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Decreased appetite	23.1% 3/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	34.9% 130/373 • Number of events 218 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	30.1% 112/372 • Number of events 150 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Dehydration	15.4% 2/13 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.9% 11/373 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	10.5% 39/373 • Number of events 69 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.9% 33/372 • Number of events 56 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 28 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.1% 19/372 • Number of events 26 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	10.5% 39/373 • Number of events 81 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.5% 28/372 • Number of events 51 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hypocalcaemia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.1% 19/373 • Number of events 26 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.8% 18/372 • Number of events 22 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hypokalaemia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	10.5% 39/373 • Number of events 59 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.3% 27/372 • Number of events 41 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hypomagnesaemia	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	9.7% 36/373 • Number of events 59 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.8% 29/372 • Number of events 42 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hyponatraemia	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	11.8% 44/373 • Number of events 72 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.3% 31/372 • Number of events 64 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.5% 54/373 • Number of events 72 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.9% 33/372 • Number of events 38 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Arthritis	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/372 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Back pain	46.2% 6/13 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	11.8% 44/373 • Number of events 52 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	11.3% 42/372 • Number of events 47 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Joint swelling	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.1% 19/373 • Number of events 20 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.3% 16/372 • Number of events 19 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Myositis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.6% 32/373 • Number of events 43 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.6% 17/372 • Number of events 18 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Cognitive disorder	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Dizziness	23.1% 3/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	10.5% 39/373 • Number of events 50 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	9.7% 36/372 • Number of events 42 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Dizziness postural	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Dysgeusia	30.8% 4/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.0% 26/373 • Number of events 28 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.1% 19/372 • Number of events 22 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Encephalitis autoimmune	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Headache	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	12.1% 45/373 • Number of events 64 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	9.4% 35/372 • Number of events 44 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Lethargy	23.1% 3/13 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 23 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.8% 18/372 • Number of events 19 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Peripheral sensory neuropathy	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.6% 6/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.2% 8/372 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Post herpetic neuralgia	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Tremor	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Nervous system disorders Vocal cord paralysis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Anxiety	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/373 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 12 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Confusional state	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Psychiatric disorders Insomnia	15.4% 2/13 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.0% 26/373 • Number of events 28 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.6% 32/372 • Number of events 43 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Dysuria	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Proteinuria	23.1% 3/13 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.7% 55/373 • Number of events 114 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	7.0% 26/372 • Number of events 37 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Renal and urinary disorders Urinary incontinence	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Reproductive system and breast disorders Breast pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Reproductive system and breast disorders Erectile dysfunction	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Reproductive system and breast disorders Pelvic pain	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.80% 3/373 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Cough	30.8% 4/13 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	17.4% 65/373 • Number of events 82 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	13.4% 50/372 • Number of events 60 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	23.1% 3/13 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	8.3% 31/373 • Number of events 36 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.2% 12/372 • Number of events 12 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.1% 3/13 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	16.9% 63/373 • Number of events 78 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	17.7% 66/372 • Number of events 68 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/373 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	23.1% 3/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.7% 55/373 • Number of events 86 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.6% 17/372 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.7% 1/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 23 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.8% 14/372 • Number of events 20 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	30.8% 4/13 • Number of events 8 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.8% 18/373 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.6% 21/372 • Number of events 30 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	23.1% 3/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.4% 20/373 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.3% 5/372 • Number of events 5 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	5.9% 22/372 • Number of events 22 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	15.4% 2/13 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/373 • Number of events 19 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	6.2% 23/372 • Number of events 25 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.9% 7/373 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.9% 11/373 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.0% 11/372 • Number of events 12 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Alopecia	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.3% 16/373 • Number of events 19 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	4.0% 15/372 • Number of events 15 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Dry skin	30.8% 4/13 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.8% 14/373 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.5% 13/372 • Number of events 14 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Pain of skin	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	15.4% 2/13 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.5% 13/373 • Number of events 13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Pruritus	23.1% 3/13 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	12.1% 45/373 • Number of events 56 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	12.9% 48/372 • Number of events 68 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Rash	30.8% 4/13 • Number of events 7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	17.2% 64/373 • Number of events 86 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	15.3% 57/372 • Number of events 64 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Rash vesicular	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Skin and subcutaneous tissue disorders Skin lesion	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Hot flush	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.54% 2/373 • Number of events 2 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Hypertension	69.2% 9/13 • Number of events 10 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	29.5% 110/373 • Number of events 158 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	11.8% 44/372 • Number of events 46 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Vascular disorders Orthostatic hypotension	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Cardiac disorders Degenerative aortic valve disease	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/373 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Infections and infestations Gastroenteritis	7.7% 1/13 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/372 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/373 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.27% 1/372 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Blood urea increased	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.5% 13/373 • Number of events 18 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	3.2% 12/372 • Number of events 21 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Investigations Urinary occult blood positive	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	1.1% 4/373 • Number of events 6 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.81% 3/372 • Number of events 4 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.9% 11/373 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.4% 9/372 • Number of events 20 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/3 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	14.3% 1/7 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/13 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.7% 10/373 • Number of events 11 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	2.2% 8/372 • Number of events 9 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	33.3% 1/3 • Number of events 1 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.	0.00% 0/7 • Up to approximately 58 months All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. AEs occurring during second course treatment were collected and presented separately from those occurring during the initial treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER