Trial Outcomes & Findings for A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407) (NCT NCT02775435)

Last Updated: 2024-10-08

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

559 participants

Primary outcome timeframe

Up to approximately 19 months

Results posted on

2024-10-08

Participant Flow

Per protocol, response/progression, or adverse events during the second and switch-over pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures.

Participant milestones

Participant milestones
Measure	Pembrolizumab + Chemotherapy Combo Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Overall Study STARTED	278	281
Overall Study Treated	278	280
Overall Study Received Second Course of Pembrolizumab	12	0
Overall Study Received Switch-over Plus Second Course of Pembrolizuamb	0	1
Overall Study Switched to Pembrolizumab + Chemotherapy	0	118
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	278	281

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab + Chemotherapy Combo Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Overall Study Adverse Event	32	27
Overall Study Lost to Follow-up	2	2
Overall Study Sponsor decision	44	19
Overall Study Withdrawal by Subject	4	9
Overall Study Death	196	224

Baseline Characteristics

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Chemotherapy Combo n=278 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=281 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).	Total n=559 Participants Total of all reporting groups
Age, Continuous	65.0 Years STANDARD_DEVIATION 8.8 • n=5 Participants	64.8 Years STANDARD_DEVIATION 8.7 • n=7 Participants	64.9 Years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	46 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	220 Participants n=5 Participants	235 Participants n=7 Participants	455 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	56 Participants n=5 Participants	52 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	216 Participants n=5 Participants	214 Participants n=7 Participants	430 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) TPS <1%	95 Participants n=5 Participants	99 Participants n=7 Participants	194 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) TPS ≥1%	176 Participants n=5 Participants	177 Participants n=7 Participants	353 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) Unknown	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Taxane Chemotherapy +Paclitaxel	169 Participants n=5 Participants	167 Participants n=7 Participants	336 Participants n=5 Participants
Taxane Chemotherapy +Nab-paclitaxel	109 Participants n=5 Participants	114 Participants n=7 Participants	223 Participants n=5 Participants
Geographic Region East Asia	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Geographic Region Non-East Asia	224 Participants n=5 Participants	229 Participants n=7 Participants	453 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 19 months

Population: The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy Combo n=278 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=281 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	6.4 Months Interval 6.2 to 8.3	4.8 Months Interval 4.3 to 5.7

PRIMARY outcome

Timeframe: Up to approximately 19 months

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

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy Combo n=278 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=281 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Overall Survival (OS)	15.9 Months Interval 13.2 to NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	11.3 Months Interval 9.5 to 14.8

SECONDARY outcome

Timeframe: Up to approximately 19 months

ORR was defined as the percentage of participants who had 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) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy Combo n=278 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=281 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	57.9 Percentage of Participants Interval 51.9 to 63.8	38.4 Percentage of Participants Interval 32.7 to 44.4

SECONDARY outcome

Timeframe: Up to approximately 19 months

Population: The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.

For participants who demonstrated a confirmed response (Complete Response \[CR\]: Disappearance of all target lesions or Partial Response \[PR\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death. DOR as assessed by blinded independent central review per RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy Combo n=161 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=108 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	7.7 Months Interval 1.1 to 14.7	4.8 Months Interval 1.3 to 15.8

SECONDARY outcome

Timeframe: Up to approximately 83 months

Population: The Safety population consisted of all participants who received ≥1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced an AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy Combo n=278 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=280 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Number of Participants Who Experienced an Adverse Event (AE)	274 Participants	275 Participants

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The Safety population consisted of all participants who received ≥1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Chemotherapy Combo n=278 Participants Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).	Placebo + Chemotherapy n=280 Participants Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	80 Participants	37 Participants

Adverse Events

Pembrolizumab + Chemotherapy Combo

Serious events: 128 serious events

Other events: 270 other events

Deaths: 225 deaths

Placebo + Chemotherapy

Serious events: 114 serious events

Other events: 272 other events

Deaths: 143 deaths

Placebo Switched Over to Pembrolizumab

Serious events: 35 serious events

Other events: 90 other events

Deaths: 111 deaths

Pembrolizumab Combo (Second Course)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 6 deaths

Placebo Switched Over to Pembrolizumab (Second Course)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab + Chemotherapy Combo n=278 participants at risk Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Placebo + Chemotherapy n=280 participants at risk Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Placebo Switched Over to Pembrolizumab n=118 participants at risk Participants who received saline placebo with chemotherapy and who experienced disease progression, switched over to receive pembrolizumab monotherapy at investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for 35 cycles (\~ 2 years).	Pembrolizumab Combo (Second Course) n=12 participants at risk Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and were deemed to be benefitting clinically despite progression, received a second course of pembrolizumab at the investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year additional).	Placebo Switched Over to Pembrolizumab (Second Course) n=1 participants at risk Participants who switched from saline placebo to complete the first course of up to 35 administrations of pembrolizumab (\~2 years), initiated a second course of pembrolizumab at investigator's discretion. Pembrolizumab was administered 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year).
Blood and lymphatic system disorders Anaemia	1.8% 5/278 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 7/280 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Eosinophilia	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Febrile neutropenia	5.4% 15/278 • Number of events 15 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.6% 10/280 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Leukopenia	1.4% 4/278 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Neutropenia	2.5% 7/278 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.9% 8/280 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Splenic haematoma	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Thrombocytopenia	2.2% 6/278 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Acute coronary syndrome	0.36% 1/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Acute myocardial infarction	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Atrial fibrillation	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Atrial flutter	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Atrioventricular block	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Cardiac arrest	1.4% 4/278 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Cardiac failure	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Coronary artery disease	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Myocardial infarction	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Pericardial effusion	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Cardiac disorders Prinzmetal angina	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Autoimmune thyroiditis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Hyperthyroidism	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Hypophysitis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Hypopituitarism	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Hypothyroidism	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Eye disorders Cataract	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Abdominal pain	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Autoimmune colitis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Colitis	2.2% 6/278 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Constipation	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Diarrhoea	2.9% 8/278 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.1% 6/280 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Duodenitis	0.72% 2/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Dysphagia	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Enterocolitis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Ileus	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Intestinal perforation	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Nausea	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Oesophageal stenosis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Vomiting	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Asthenia	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.8% 5/280 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Chest pain	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Death	2.2% 6/278 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Fatigue	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders General physical health deterioration	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Malaise	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Multiple organ dysfunction syndrome	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Oedema peripheral	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Pyrexia	1.8% 5/278 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.8% 5/280 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Autoimmune hepatitis	1.1% 3/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Bile duct stone	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Cholangitis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Cholecystitis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Cholecystitis acute	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Cholelithiasis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Hepatic failure	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Hepatitis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Immune system disorders Amyloidosis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Immune system disorders Drug hypersensitivity	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Appendiceal abscess	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Biliary tract infection	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Blister infected	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Bronchitis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations COVID-19 pneumonia	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Campylobacter colitis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Candida infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Clostridium difficile colitis	0.36% 1/278 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Device related infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Hepatitis B	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Hepatitis E	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Kidney infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Klebsiella infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Large intestine infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Lower respiratory tract infection	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Lung abscess	0.72% 2/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Meningitis pneumococcal	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Necrotising fasciitis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Oral candidiasis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pneumonia	7.9% 22/278 • Number of events 23 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.5% 21/280 • Number of events 23 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pneumonia bacterial	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pneumonia fungal	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pneumonia klebsiella	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pneumonia legionella	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Prostatic abscess	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pulmonary sepsis	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pyelonephritis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Respiratory tract infection	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Sepsis	2.2% 6/278 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Septic shock	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Stoma site infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Tracheobronchitis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Upper respiratory tract infection	0.72% 2/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Urinary tract infection	0.72% 2/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Urosepsis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Vascular device infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Injury, poisoning and procedural complications Infusion related reaction	1.8% 5/278 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Injury, poisoning and procedural complications Spinal compression fracture	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Alanine aminotransferase increased	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Decreased appetite	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Dehydration	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Diabetes mellitus	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.8% 5/280 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hyperkalaemia	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hyponatraemia	0.72% 2/278 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Back pain	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.7% 2/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Balance disorder	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Carotid artery occlusion	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Carotid artery stenosis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Cerebral infarction	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Cerebral ischaemia	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Cerebrovascular accident	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Dysarthria	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Epilepsy	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Facial paralysis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Headache	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Intercostal neuralgia	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Ischaemic stroke	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Neuropathy peripheral	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Sciatica	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Seizure	1.1% 3/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Spinal cord compression	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Syncope	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Transient ischaemic attack	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Uraemic encephalopathy	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Psychiatric disorders Delirium	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Renal and urinary disorders Acute kidney injury	0.72% 2/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.4% 4/280 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Renal and urinary disorders Glomerulonephritis membranous	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Renal and urinary disorders Haematuria	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Renal and urinary disorders Nephritis	0.36% 1/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Renal and urinary disorders Tubulointerstitial nephritis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Renal and urinary disorders Urinary retention	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 3/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.7% 2/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.2% 6/278 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.4% 4/280 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.7% 2/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 4/278 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 9/278 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pneumonitis aspiration	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 3/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 3/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	1.1% 3/278 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 4/278 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Psoriasis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Arterial disorder	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Arterial haemorrhage	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Circulatory collapse	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Deep vein thrombosis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Embolism	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Hypotension	0.72% 2/278 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Orthostatic hypotension	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Superficial vein thrombosis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Superior vena cava syndrome	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Thrombophlebitis migrans	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.36% 1/280 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Vasculitis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.

Other adverse events

Other adverse events
Measure	Pembrolizumab + Chemotherapy Combo n=278 participants at risk Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Placebo + Chemotherapy n=280 participants at risk Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.	Placebo Switched Over to Pembrolizumab n=118 participants at risk Participants who received saline placebo with chemotherapy and who experienced disease progression, switched over to receive pembrolizumab monotherapy at investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for 35 cycles (\~ 2 years).	Pembrolizumab Combo (Second Course) n=12 participants at risk Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and were deemed to be benefitting clinically despite progression, received a second course of pembrolizumab at the investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year additional).	Placebo Switched Over to Pembrolizumab (Second Course) n=1 participants at risk Participants who switched from saline placebo to complete the first course of up to 35 administrations of pembrolizumab (\~2 years), initiated a second course of pembrolizumab at investigator's discretion. Pembrolizumab was administered 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year).
Blood and lymphatic system disorders Anaemia	53.2% 148/278 • Number of events 200 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	49.6% 139/280 • Number of events 186 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	14.4% 17/118 • Number of events 26 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Leukopenia	7.2% 20/278 • Number of events 46 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.1% 20/280 • Number of events 40 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Neutropenia	35.6% 99/278 • Number of events 201 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	30.4% 85/280 • Number of events 166 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Blood and lymphatic system disorders Thrombocytopenia	29.1% 81/278 • Number of events 131 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	22.9% 64/280 • Number of events 95 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Hyperthyroidism	7.2% 20/278 • Number of events 22 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.71% 2/280 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Endocrine disorders Hypothyroidism	11.9% 33/278 • Number of events 36 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.1% 6/280 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Abdominal pain	7.9% 22/278 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.1% 17/280 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 3/118 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Constipation	25.2% 70/278 • Number of events 93 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	22.1% 62/280 • Number of events 74 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	10.2% 12/118 • Number of events 14 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Diarrhoea	31.7% 88/278 • Number of events 141 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	23.2% 65/280 • Number of events 86 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	13.6% 16/118 • Number of events 22 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Dry mouth	3.6% 10/278 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.1% 6/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Dysphagia	1.8% 5/278 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.1% 6/280 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 3/118 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Nausea	36.3% 101/278 • Number of events 151 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	32.1% 90/280 • Number of events 136 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	10.2% 12/118 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Stomatitis	5.0% 14/278 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.4% 15/280 • Number of events 16 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.7% 2/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Gastrointestinal disorders Vomiting	18.3% 51/278 • Number of events 71 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	10.7% 30/280 • Number of events 47 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.1% 6/118 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Asthenia	22.3% 62/278 • Number of events 83 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	21.4% 60/280 • Number of events 72 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.8% 8/118 • Number of events 16 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Chest pain	7.2% 20/278 • Number of events 21 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.6% 24/280 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.6% 9/118 • Number of events 10 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Fatigue	24.1% 67/278 • Number of events 92 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	25.7% 72/280 • Number of events 102 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	12.7% 15/118 • Number of events 15 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Oedema peripheral	9.4% 26/278 • Number of events 27 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.9% 22/280 • Number of events 30 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 3/118 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
General disorders Pyrexia	14.0% 39/278 • Number of events 45 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	12.5% 35/280 • Number of events 41 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Hepatobiliary disorders Cholestasis	0.36% 1/278 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Bronchitis	7.9% 22/278 • Number of events 25 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.9% 11/280 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Nasopharyngitis	7.2% 20/278 • Number of events 27 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 7/280 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.7% 2/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Pneumonia	5.0% 14/278 • Number of events 16 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.7% 16/280 • Number of events 16 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Stoma site infection	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Upper respiratory tract infection	7.2% 20/278 • Number of events 30 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.6% 10/280 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Infections and infestations Urinary tract infection	5.8% 16/278 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.9% 8/280 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Alanine aminotransferase increased	8.3% 23/278 • Number of events 39 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.3% 12/280 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	16.7% 2/12 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Aspartate aminotransferase increased	9.4% 26/278 • Number of events 40 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.7% 16/280 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.1% 6/118 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	16.7% 2/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Blood alkaline phosphatase increased	4.3% 12/278 • Number of events 19 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.3% 12/280 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Blood bilirubin increased	1.8% 5/278 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.1% 3/280 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 3/118 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Blood creatinine increased	9.4% 26/278 • Number of events 37 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.4% 15/280 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	9.3% 11/118 • Number of events 20 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Neutrophil count decreased	8.6% 24/278 • Number of events 59 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	10.0% 28/280 • Number of events 60 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Platelet count decreased	9.0% 25/278 • Number of events 52 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.2% 23/280 • Number of events 42 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations Weight decreased	11.2% 31/278 • Number of events 33 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.6% 24/280 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	9.3% 11/118 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Investigations White blood cell count decreased	11.5% 32/278 • Number of events 78 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	11.4% 32/280 • Number of events 61 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Decreased appetite	27.7% 77/278 • Number of events 120 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	29.3% 82/280 • Number of events 101 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.6% 9/118 • Number of events 11 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypercalcaemia	2.9% 8/278 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 7/280 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.8% 8/118 • Number of events 10 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hyperglycaemia	4.0% 11/278 • Number of events 14 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.3% 12/280 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypoalbuminaemia	5.4% 15/278 • Number of events 21 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.3% 12/280 • Number of events 19 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypocalcaemia	2.5% 7/278 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.4% 18/280 • Number of events 27 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypokalaemia	6.5% 18/278 • Number of events 31 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.8% 19/280 • Number of events 28 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.8% 8/118 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypomagnesaemia	8.6% 24/278 • Number of events 36 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.5% 21/280 • Number of events 27 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hyponatraemia	7.2% 20/278 • Number of events 28 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.6% 13/280 • Number of events 14 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	16.7% 2/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Metabolism and nutrition disorders Hypophosphataemia	2.5% 7/278 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.9% 11/280 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Arthralgia	25.2% 70/278 • Number of events 103 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	17.1% 48/280 • Number of events 61 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.5% 10/118 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Back pain	8.6% 24/278 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	13.2% 37/280 • Number of events 38 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 37/278 • Number of events 47 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	12.1% 34/280 • Number of events 41 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 3/118 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 23/278 • Number of events 31 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	9.6% 27/280 • Number of events 36 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Dizziness	7.6% 21/278 • Number of events 25 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	7.1% 20/280 • Number of events 23 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Dysgeusia	8.6% 24/278 • Number of events 27 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.9% 11/280 • Number of events 11 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	1.7% 2/118 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Headache	9.0% 25/278 • Number of events 28 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.2% 23/280 • Number of events 27 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Neuropathy peripheral	21.6% 60/278 • Number of events 69 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	17.1% 48/280 • Number of events 56 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Paraesthesia	7.6% 21/278 • Number of events 22 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.7% 16/280 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Nervous system disorders Peripheral sensory neuropathy	11.9% 33/278 • Number of events 34 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	13.2% 37/280 • Number of events 39 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Psychiatric disorders Anxiety	5.4% 15/278 • Number of events 17 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.9% 8/280 • Number of events 9 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Psychiatric disorders Insomnia	11.2% 31/278 • Number of events 32 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.2% 23/280 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.2% 5/118 • Number of events 5 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Cough	17.6% 49/278 • Number of events 55 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	20.0% 56/280 • Number of events 66 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	10.2% 12/118 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.7% 41/278 • Number of events 46 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	16.1% 45/280 • Number of events 49 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	12.7% 15/118 • Number of events 15 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	16.7% 2/12 • Number of events 2 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.7% 27/278 • Number of events 32 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.8% 19/280 • Number of events 21 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Haemoptysis	8.3% 23/278 • Number of events 24 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.9% 25/280 • Number of events 36 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	10.2% 12/118 • Number of events 14 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Hiccups	5.0% 14/278 • Number of events 21 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.1% 6/280 • Number of events 6 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Respiratory, thoracic and mediastinal disorders Productive cough	6.5% 18/278 • Number of events 21 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	4.6% 13/280 • Number of events 15 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	6.8% 8/118 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Alopecia	46.0% 128/278 • Number of events 129 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	37.5% 105/280 • Number of events 106 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Dry skin	4.3% 12/278 • Number of events 12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.9% 8/280 • Number of events 8 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.85% 1/118 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Pruritus	18.3% 51/278 • Number of events 61 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.9% 25/280 • Number of events 29 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	12.7% 15/118 • Number of events 18 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Rash	18.7% 52/278 • Number of events 62 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	11.4% 32/280 • Number of events 37 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.9% 7/118 • Number of events 7 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/278 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/280 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/118 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Hypertension	6.5% 18/278 • Number of events 22 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.0% 14/280 • Number of events 15 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	2.5% 3/118 • Number of events 3 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/12 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
Vascular disorders Hypotension	4.3% 12/278 • Number of events 13 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	5.7% 16/280 • Number of events 19 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	3.4% 4/118 • Number of events 4 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	8.3% 1/12 • Number of events 1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.	0.00% 0/1 • Up to approximately 83 months All-Cause Mortality (ACM): all randomized participants. AEs: all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.

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