Trial Outcomes & Findings for A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma (NCT NCT03273153)

NCT ID: NCT03273153

Last Updated: 2022-09-21

Results Overview

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 446 participants
• Primary outcome timeframe: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months
• Results posted on: 2022-09-21

Participant Flow

Participant milestones

Measure	Pembrolizumab Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Overall Study STARTED	224	222
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	224	222

Reasons for withdrawal

Measure	Pembrolizumab Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Overall Study Adverse Event	1	2
Overall Study Missing	0	2
Overall Study Other	3	2
Overall Study Symptomatic Deterioration	0	1
Overall Study Progressive Disease	6	5
Overall Study Physician Decision	1	3
Overall Study Study Terminated by Sponsor	112	102
Overall Study Withdrawal by Subject	26	25
Overall Study Protocol Deviation	3	0
Overall Study Lost to Follow-up	6	11
Overall Study Death	66	69

Baseline Characteristics

A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Baseline characteristics by cohort

Measure	Pembrolizumab n=224 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.	Total n=446 Participants Total of all reporting groups
Age, Continuous	63.5 Years STANDARD_DEVIATION 12.9 • n=5 Participants	63.6 Years STANDARD_DEVIATION 13.1 • n=7 Participants	63.6 Years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	93 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	129 Participants n=7 Participants	270 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=5 Participants	180 Participants n=7 Participants	370 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	198 Participants n=5 Participants	188 Participants n=7 Participants	386 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	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Pembrolizumab n=224 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC)	5.7 Months Interval 3.7 to 9.6	5.5 Months Interval 3.8 to 7.2

SECONDARY outcome

Timeframe: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Pembrolizumab n=224 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
PFS as Determined by the Investigator	7.2 Months Interval 3.8 to 10.1	5.6 Months Interval 3.9 to 6.6

SECONDARY outcome

Timeframe: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

Objective response rate is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator through the use of RECIST v1.1. For target lesion, CR: the disappearance of all target lesions, any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. For non-target lesion, CR: the disappearance of all non-target lesions and (if applicable) normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis).

Outcome measures

Measure	Pembrolizumab n=221 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Objective Response as Determined by the Investigator	36.7 Percentage of Participants Interval 30.29 to 43.38	27.9 Percentage of Participants Interval 22.13 to 34.32

SECONDARY outcome

Timeframe: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

Objective response, defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by IRC according to RECIST v1.1

Outcome measures

Measure	Pembrolizumab n=206 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=204 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Objective Response as Determined by IRC	31.6 Percentage of Participants Interval 25.27 to 38.38	26.0 Percentage of Participants Interval 20.11 to 32.57

SECONDARY outcome

Timeframe: Week 16

Population: The analysis for this outcome measure was limited to participants meeting the criteria provided in the description.

DCR is defined as the proportion of participants with a complete response, a partial response, or stable disease at 16 weeks. For target lesion, CR: the disappearance of all target lesions, any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. For non-target lesion, CR: the disappearance of all non-target lesions and (if applicable) normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). Stable disease (SD): neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.

Outcome measures

Measure	Pembrolizumab n=221 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Disease Control Rate (DCR) Investigator-assessed	49.8 Percentage of Participants Interval 43.0 to 56.56	46.8 Percentage of Participants Interval 40.14 to 53.64
Disease Control Rate (DCR) IRC-assessed	44.2 Percentage of Participants Interval 37.28 to 51.24	45.6 Percentage of Participants Interval 38.62 to 52.69

SECONDARY outcome

Timeframe: From randomization up to approximately 3 years

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

Outcome measures

Measure	Pembrolizumab n=224 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Overall Survival (OS)	29.3 Months Interval 21.5 to Values are not estimable due to an insufficient number of participants with the event.	NA Months Interval 24.1 to Values are not estimable due to an insufficient number of participants with the event.

SECONDARY outcome

Timeframe: Every 8 weeks (wks) from Day (D) 1 of Cycle (C) 1 through approximately 16 months

Duration of objective response, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first.

Outcome measures

Measure	Pembrolizumab n=206 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=204 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Duration of Objective Response Determined by the IRC	NA Months Values are not estimable due to an insufficient number of participants with the event.	NA Months Interval 9.2 to Values are not estimable due to an insufficient number of participants with the event.

SECONDARY outcome

Timeframe: Up to 3 years

Duration of objective response is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first.

Outcome measures

Measure	Pembrolizumab n=221 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Duration of Objective Response Determined by the Investigator	NA Months Values are not estimable due to an insufficient number of participants with the event.	NA Months Interval 9.2 to Values are not estimable due to an insufficient number of participants with the event.

SECONDARY outcome

Timeframe: At 2 years

Two-year landmark survival is defined as the rate of survival at 2 years. Two-year landmark survival is defined as the rate of survival at 2 years and was calculated using Kaplan-Meier analysis, which is commonly used to estimate the probability of an event at time 't.'

Outcome measures

Measure	Pembrolizumab n=224 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=222 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Two-year Landmark Survival	57.88 Percentage Interval 48.25 to 67.52	60.19 Percentage Interval 51.58 to 68.79

SECONDARY outcome

Timeframe: Up to approximately 16 months. Follow up is reported at weeks after participant treatment discontinuation, which could occur at any time during the study. Total time frame does not exceed 16 months.

Population: The analysis population for this endpoint was the patient reported outcome (PRO) population evaluable participants for EORTC QLQ-C30.

HRQoL scores are assessed through global health status (GHS)/ quality of life (QoL) subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). These are based on questions 29 and 30 of the EORTC QLQ-C30. These questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Raw scores will be linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher ("better") level of functioning.

Outcome measures

Measure	Pembrolizumab n=174 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=160 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Baseline value	73.27 Units on a Scale Standard Deviation 20.41	73.85 Units on a Scale Standard Deviation 19.73
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 4	-2.99 Units on a Scale Standard Deviation 17.05	-9.14 Units on a Scale Standard Deviation 20.83
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 8	-3.15 Units on a Scale Standard Deviation 18.67	-5.21 Units on a Scale Standard Deviation 18.18
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 12	-1.77 Units on a Scale Standard Deviation 19.93	-7.65 Units on a Scale Standard Deviation 21.20
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 16	1.16 Units on a Scale Standard Deviation 15.02	-6.44 Units on a Scale Standard Deviation 20.58
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 20	1.69 Units on a Scale Standard Deviation 17.50	-6.31 Units on a Scale Standard Deviation 19.17
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 24	-1.84 Units on a Scale Standard Deviation 19.82	-2.49 Units on a Scale Standard Deviation 15.98
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 28	2.46 Units on a Scale Standard Deviation 19.07	-3.86 Units on a Scale Standard Deviation 19.10
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 32	-0.88 Units on a Scale Standard Deviation 22.41	-4.66 Units on a Scale Standard Deviation 20.94
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 36	4.17 Units on a Scale Standard Deviation 20.56	-6.00 Units on a Scale Standard Deviation 18.24
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 40	7.22 Units on a Scale Standard Deviation 19.38	-4.63 Units on a Scale Standard Deviation 21.62
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 44	0.46 Units on a Scale Standard Deviation 19.27	1.67 Units on a Scale Standard Deviation 12.91
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 48	7.64 Units on a Scale Standard Deviation 13.04	0.00 Units on a Scale Standard Deviation 15.96
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 52	1.67 Units on a Scale Standard Deviation 12.36	8.33 Units on a Scale Standard Deviation 15.21
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 56	-11.11 Units on a Scale Standard Deviation 17.21	-2.08 Units on a Scale Standard Deviation 4.17
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 60	-8.33 Units on a Scale Standard Deviation 11.79	-4.17 Units on a Scale Standard Deviation 5.89
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Week 64	33.33 Units on a Scale Standard Deviation NA Value is NA due to an insufficient number of participants with the event at this timepoint.	—
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Treatment Discontinuation	-6.05 Units on a Scale Standard Deviation 22.53	-14.42 Units on a Scale Standard Deviation 25.68
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 4	-7.64 Units on a Scale Standard Deviation 14.85	-2.27 Units on a Scale Standard Deviation 18.67
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 8	-14.25 Units on a Scale Standard Deviation 21.96	-14.10 Units on a Scale Standard Deviation 24.15
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 12	-21.38 Units on a Scale Standard Deviation 24.34	-24.31 Units on a Scale Standard Deviation 28.08
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 16	-13.73 Units on a Scale Standard Deviation 19.53	-23.61 Units on a Scale Standard Deviation 23.26
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 20	-20.83 Units on a Scale Standard Deviation 26.53	-8.33 Units on a Scale Standard Deviation 12.91
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 24	-17.71 Units on a Scale Standard Deviation 29.36	-10.00 Units on a Scale Standard Deviation 14.91
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Follow-up 28	-27.78 Units on a Scale Standard Deviation 22.15	-16.67 Units on a Scale Standard Deviation 23.57

SECONDARY outcome

Timeframe: Up to approximately 16 months

An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Measure	Pembrolizumab n=216 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=220 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Number of Participants With Adverse Events (AEs)	195 Number of Participants	218 Number of Participants

SECONDARY outcome

Timeframe: From baseline up to approximately 3 years

Population: N for each assessment = participants without abnormalities at baseline or with missing baseline values

Vital signs will include temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure.

Outcome measures

Measure	Pembrolizumab n=216 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=220 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Number of Participants With Abnormal Vital Signs Sitting diastolic blood pressure - low	41 Participants	42 Participants
Number of Participants With Abnormal Vital Signs Sitting diastolic blood pressure - high	77 Participants	85 Participants
Number of Participants With Abnormal Vital Signs Sitting systolic blood pressure - low	4 Participants	7 Participants
Number of Participants With Abnormal Vital Signs Sitting systolic blood pressure - high	53 Participants	47 Participants
Number of Participants With Abnormal Vital Signs Pulse rate - low	58 Participants	67 Participants
Number of Participants With Abnormal Vital Signs Pulse rate - high	13 Participants	27 Participants
Number of Participants With Abnormal Vital Signs Respiratory rate - low	8 Participants	11 Participants
Number of Participants With Abnormal Vital Signs Respiratory rate - high	55 Participants	52 Participants
Number of Participants With Abnormal Vital Signs Temperature - low	91 Participants	93 Participants
Number of Participants With Abnormal Vital Signs Temperature - high	20 Participants	47 Participants

SECONDARY outcome

Timeframe: Up to approximately 16 months

Population: Participants with at least one post-baseline assessment for a given laboratory value were included in this assessment.

Participants with laboratory abnormalities (values outside of a defined range) will be reported.

Outcome measures

Measure	Pembrolizumab n=216 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=220 Participants Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Number of Participants With Laboratory Abnormalities SGPT/ALT	1 Number of Participants	1 Number of Participants
Number of Participants With Laboratory Abnormalities Amylase	4 Number of Participants	5 Number of Participants
Number of Participants With Laboratory Abnormalities SGOT/AST	0 Number of Participants	2 Number of Participants
Number of Participants With Laboratory Abnormalities Calcium	0 Number of Participants	1 Number of Participants
Number of Participants With Laboratory Abnormalities Creatine Kinase	1 Number of Participants	17 Number of Participants
Number of Participants With Laboratory Abnormalities Creatinine	1 Number of Participants	4 Number of Participants
Number of Participants With Laboratory Abnormalities Glucose	8 Number of Participants	13 Number of Participants
Number of Participants With Laboratory Abnormalities Triacylglycerol Lipase	8 Number of Participants	10 Number of Participants
Number of Participants With Laboratory Abnormalities Magnesium	3 Number of Participants	2 Number of Participants
Number of Participants With Laboratory Abnormalities Phosphorus	6 Number of Participants	10 Number of Participants
Number of Participants With Laboratory Abnormalities Potassium	1 Number of Participants	6 Number of Participants
Number of Participants With Laboratory Abnormalities Sodium	2 Number of Participants	4 Number of Participants
Number of Participants With Laboratory Abnormalities Uric Acid	36 Number of Participants	30 Number of Participants
Number of Participants With Laboratory Abnormalities Hemoglobin	2 Number of Participants	2 Number of Participants
Number of Participants With Laboratory Abnormalities Lymphocytes Abs	6 Number of Participants	15 Number of Participants
Number of Participants With Laboratory Abnormalities Neutrophils, Total, Abs	0 Number of Participants	1 Number of Participants
Number of Participants With Laboratory Abnormalities Total Leukocyte Count	3 Number of Participants	0 Number of Participants

SECONDARY outcome

Timeframe: Days 1 and 15 of Cycle 1

Population: PK data was not available from all participants at all time points due to study continuation or missed PK sampling.

Outcome measures

Measure	Pembrolizumab n=202 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Plasma Concentration of Cobimetinib Cycle 1 Day 1	49.2 nanograms/mL Geometric Coefficient of Variation 614.7	—
Plasma Concentration of Cobimetinib Cycle 1 Day 15 pre-dose	126 nanograms/mL Geometric Coefficient of Variation 284.1	—
Plasma Concentration of Cobimetinib Cycle 1 Day 15 post-dose	231 nanograms/mL Geometric Coefficient of Variation 213.3	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, and 3

Population: PK data was not available from all participants at all time points due to study continuation or missed PK sampling.

Outcome measures

Measure	Pembrolizumab n=196 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Serum Concentration of Atezolizumab Cycle 1 Day 1	256 micrograms/mL Geometric Coefficient of Variation 35.3	—
Serum Concentration of Atezolizumab Cycle 2 Day 1	72.2 micrograms/mL Geometric Coefficient of Variation 177.1	—
Serum Concentration of Atezolizumab Cycle 3 Day 1	126 micrograms/mL Geometric Coefficient of Variation 104.3	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1, 2, 3 and 30 days after treatment discontinuation

Population: Only participants from the Cobimetinib and Atezolizumab arm are included in this endpoint as it is meant to evaluate the immune response to atezolizumab.

Participants with ADAs during the study relative to the prevalence of ADAs at baseline will be reported.

Outcome measures

Measure	Pembrolizumab n=210 Participants Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Percentage of Participants With Anti-drug Antibodies (ADAs)	23.2 Percentage of participants	—

Adverse Events

Pembrolizumab

Serious events: 56 serious events

Other events: 173 other events

Deaths: 68 deaths

Cobimetinib and Atezolizumab

Serious events: 105 serious events

Other events: 209 other events

Deaths: 70 deaths

Serious adverse events

Measure	Pembrolizumab n=216 participants at risk Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=220 participants at risk Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
General disorders Malaise	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Multiple organ dysfunction syndrome	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Diarrhoea	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	4.1% 9/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Vomiting	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	2.3% 5/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Abdominal pain upper	1.4% 3/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Colitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Nausea	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Autoimmune colitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Haematochezia	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Pancreatitis	1.4% 3/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Stomatitis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Pyrexia	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.5% 12/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Asthenia	1.4% 3/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.8% 4/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Fatigue	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders General physical health deterioration	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Erysipelas	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Diarrhoea infectious	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Encephalitis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Infection	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Ischaemic stroke	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Seizure	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Syncope	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Autoimmune encephalopathy	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Encephalitis autoimmune	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Leukoencephalopathy	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Presyncope	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 5/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Blood bilirubin increased	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Blood creatine phosphokinase increased	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Blood creatinine increased	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Aspartate aminotransferase increased	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Alanine aminotransferase increased	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations General physical condition abnormal	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Transaminases increased	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Rash	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.8% 4/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Atrial fibrillation	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Atrial flutter	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Angina pectoris	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Cardiac failure acute	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Myocarditis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Tachyarrhythmia	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.8% 4/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Myositis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Hyperglycaemia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Dehydration	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Hyponatraemia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Hypovolaemia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Renal and urinary disorders Renal failure	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Renal and urinary disorders Acute kidney injury	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Vascular disorders Hypotension	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Blood and lymphatic system disorders Anaemia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Eye disorders Chorioretinopathy	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Eye disorders Visual impairment	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Hepatobiliary disorders Hepatic failure	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Hepatobiliary disorders Hepatitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Endocrine disorders Adrenal insufficiency	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Immune system disorders Hypersensitivity	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Hepatobiliary disorders Autoimmune hepatitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Cardiac failure	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Hepatobiliary disorders Cholestasis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Immune-mediated neuropathy	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Renal and urinary disorders Autoimmune nephritis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Gastritis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Gastroenteritis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Lipase increased	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Urinary tract infection	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Sepsis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	2.7% 6/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Pneumonia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	1.4% 3/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Abdominal pain	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.93% 2/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Respiratory tract infection	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Urosepsis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.91% 2/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Appendicitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Ascites	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Renal and urinary disorders Bladder perforation	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Bradycardia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Brain oedema	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations COVID-19 pneumonia	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Cardiac disorders Cardiac tamponade	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Cellulitis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Chest pain	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Dacryocystitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Device related infection	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Device related sepsis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Diabetes mellitus	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Eye disorders Diplopia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Dyskinesia	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Endocarditis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Fall	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Gastric ulcer	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Vascular disorders Haematoma	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Renal and urinary disorders Haematuria	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Headache	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Hepatobiliary disorders Hepatic cirrhosis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Hepatobiliary disorders Hepatic pain	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Hip fracture	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Vascular disorders Hypertension	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Hypoglycaemia	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Vascular disorders Hypotensive crisis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Surgical and medical procedures Hysterectomy	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Influenza	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Intestinal obstruction	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Intracranial pressure increased	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Lower respiratory tract infection	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Nervous system disorder	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Non-cardiac chest pain	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Vascular disorders Orthostatic hypotension	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Pneumonia viral	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Radiculopathy	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Rectal haemorrhage	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Sinusitis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Spinal pain	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Spleen tuberculosis	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Subileus	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Superinfection viral	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Tonsilitis	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Toxic shock syndrome	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Transient ischaemic attack	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Injury, poisoning and procedural complications Upper limb fracture	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Upper respiratory tract infection	0.46% 1/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.00% 0/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Wound infection	0.00% 0/216 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	0.45% 1/220 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.

Other adverse events

Measure	Pembrolizumab n=216 participants at risk Participants received 200 mg of intravenous (IV) pembrolizumab every 3 weeks (Q3W) until investigator-determined disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurred first.	Cobimetinib and Atezolizumab n=220 participants at risk Participants received 60 mg of cobimetinib by mouth (PO) on a 21 days on, 7 days off schedule (dosing on Days 1-21, followed by no dosing on Days 22-28) plus 840 mg of atezolizumab by IV infusion of Days 1 and 15 of each 28-day cycle.
Blood and lymphatic system disorders Anaemia	7.9% 17/216 • Number of events 18 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	14.5% 32/220 • Number of events 50 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Endocrine disorders Hyperthyroidism	9.7% 21/216 • Number of events 22 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	4.5% 10/220 • Number of events 10 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Endocrine disorders Hypothyroidism	7.9% 17/216 • Number of events 17 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	6.8% 15/220 • Number of events 17 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Abdominal pain	8.3% 18/216 • Number of events 22 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	10.9% 24/220 • Number of events 29 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Constipation	9.3% 20/216 • Number of events 26 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	14.5% 32/220 • Number of events 36 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Diarrhoea	19.4% 42/216 • Number of events 58 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	54.5% 120/220 • Number of events 293 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Dry mouth	4.2% 9/216 • Number of events 9 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	8.2% 18/220 • Number of events 19 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Nausea	13.0% 28/216 • Number of events 32 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	24.5% 54/220 • Number of events 61 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Stomatitis	1.4% 3/216 • Number of events 4 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	6.4% 14/220 • Number of events 19 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Gastrointestinal disorders Vomiting	6.9% 15/216 • Number of events 16 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	18.6% 41/220 • Number of events 53 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Asthenia	19.4% 42/216 • Number of events 49 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	26.8% 59/220 • Number of events 89 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Fatigue	19.4% 42/216 • Number of events 54 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	19.5% 43/220 • Number of events 64 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Oedema peripheral	7.9% 17/216 • Number of events 20 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	22.7% 50/220 • Number of events 76 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
General disorders Pyrexia	7.9% 17/216 • Number of events 19 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	29.5% 65/220 • Number of events 87 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Folliculitis	0.93% 2/216 • Number of events 2 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	6.8% 15/220 • Number of events 24 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Rash pustular	0.93% 2/216 • Number of events 2 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.0% 11/220 • Number of events 12 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Urinary tract infection	1.9% 4/216 • Number of events 4 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.9% 13/220 • Number of events 18 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Alanine aminotransferase increased	8.3% 18/216 • Number of events 19 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	13.6% 30/220 • Number of events 42 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Amylase increased	4.2% 9/216 • Number of events 10 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	8.6% 19/220 • Number of events 29 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Aspartate aminotransferase increased	8.3% 18/216 • Number of events 20 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	19.1% 42/220 • Number of events 57 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Blood creatine phosphokinase increased	6.0% 13/216 • Number of events 16 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	36.8% 81/220 • Number of events 127 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Blood lactate dehydrogenase increased	2.3% 5/216 • Number of events 5 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	6.8% 15/220 • Number of events 19 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Lipase increased	6.9% 15/216 • Number of events 18 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	12.7% 28/220 • Number of events 51 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Decreased appetite	7.4% 16/216 • Number of events 18 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	13.6% 30/220 • Number of events 35 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Metabolism and nutrition disorders Hyperglycaemia	5.1% 11/216 • Number of events 13 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	8.6% 19/220 • Number of events 23 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Arthralgia	17.1% 37/216 • Number of events 48 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	9.5% 21/220 • Number of events 23 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Back pain	8.8% 19/216 • Number of events 29 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.5% 12/220 • Number of events 17 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 12/216 • Number of events 12 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	8.2% 18/220 • Number of events 20 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 8/216 • Number of events 9 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.0% 11/220 • Number of events 12 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Dizziness	3.7% 8/216 • Number of events 11 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	8.2% 18/220 • Number of events 23 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Headache	7.9% 17/216 • Number of events 19 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	13.6% 30/220 • Number of events 36 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Cough	10.6% 23/216 • Number of events 27 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	9.5% 21/220 • Number of events 26 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.8% 19/216 • Number of events 20 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	8.2% 18/220 • Number of events 24 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Dermatitis acneiform	1.4% 3/216 • Number of events 3 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	22.7% 50/220 • Number of events 68 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Dry skin	6.5% 14/216 • Number of events 15 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	6.8% 15/220 • Number of events 21 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Erythema	4.2% 9/216 • Number of events 12 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	7.3% 16/220 • Number of events 20 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Pruritis	16.2% 35/216 • Number of events 42 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	20.0% 44/220 • Number of events 64 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Rash	12.5% 27/216 • Number of events 37 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	40.9% 90/220 • Number of events 154 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.3% 5/216 • Number of events 7 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	11.8% 26/220 • Number of events 39 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Vascular disorders Hypertension	6.9% 15/216 • Number of events 21 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	10.9% 24/220 • Number of events 29 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Nasopharyngitis	4.6% 10/216 • Number of events 15 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.5% 12/220 • Number of events 13 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Infections and infestations Paronychia	0.46% 1/216 • Number of events 1 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.9% 13/220 • Number of events 14 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Investigations Weight decreased	5.6% 12/216 • Number of events 13 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.0% 11/220 • Number of events 13 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Nervous system disorders Paraesthesia	2.8% 6/216 • Number of events 6 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	5.0% 11/220 • Number of events 12 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.
Skin and subcutaneous tissue disorders Vitiligo	8.8% 19/216 • Number of events 20 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.	2.7% 6/220 • Number of events 6 • For up to 135 days after the last dose of study drug, or until a new systemic anti-cancer therapy was initiated, whichever occurred first (a maximum of approximately 3 years). Adverse events (serious and other) were evaluated for the safety-evaluable population, which consisted of all participants who received at least one dose of study treatment. All-cause mortality is reported for the entire study population.

Additional Information

Medical Communications

Hoffmann-La Roche

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Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER