Trial Outcomes & Findings for A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001) (NCT NCT02842827)

Last Updated: 2023-07-11

Results Overview

An AE was defined as any undesirable physical, psychological, or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not related to the study drug. This included any untoward signs or symptoms experienced by the participant from the time of first dose until completion of the study. The number of participants who experienced an AE is presented.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to approximately 24 months

Results posted on

2023-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Overall Study STARTED	3	6	4	6	5	9	4	8
Overall Study Treated	3	6	4	6	5	9	4	8
Overall Study COMPLETED	0	0	0	0	0	1	0	2
Overall Study NOT COMPLETED	3	6	4	6	5	8	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Overall Study Adverse Event	0	1	0	1	0	1	0	0
Overall Study Death	1	0	2	3	2	1	0	4
Overall Study Physician Decision	1	3	0	0	1	4	2	1
Overall Study Protocol Defined Disease Progression	0	0	0	0	0	1	0	0
Overall Study Participant Withdrawal of Consent	1	2	2	2	2	1	2	1

Baseline Characteristics

A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.	Total n=45 Participants Total of all reporting groups
Age, Continuous	72.3 Years STANDARD_DEVIATION 10.02 • n=5 Participants	74.2 Years STANDARD_DEVIATION 9.24 • n=7 Participants	74.0 Years STANDARD_DEVIATION 10.95 • n=5 Participants	66.8 Years STANDARD_DEVIATION 11.14 • n=4 Participants	67.2 Years STANDARD_DEVIATION 14.65 • n=21 Participants	71.8 Years STANDARD_DEVIATION 9.00 • n=8 Participants	68.5 Years STANDARD_DEVIATION 2.08 • n=8 Participants	70.5 Years STANDARD_DEVIATION 11.65 • n=24 Participants	70.6 Years STANDARD_DEVIATION 9.98 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	19 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	26 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants	37 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	7 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	4 Participants n=8 Participants	7 Participants n=24 Participants	39 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants
Disease Diagnosis AML	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	4 Participants n=8 Participants	7 Participants n=24 Participants	39 Participants n=42 Participants
Disease Diagnosis MDS	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	6 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants who received ≥1 dose of study treatment

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Number of Participants Who Experienced an Adverse Event (AE)	3 Participants	6 Participants	4 Participants	6 Participants	5 Participants	9 Participants	4 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants who received ≥1 dose of study treatment

An SAE was defined as any adverse event, whether or not related to the study drug, that resulted in any of the following outcomes: * Death * Life-threatening experience * Required or prolonged inpatient hospitalization * Persistent or significant disability/incapacity * Congenital anomaly * Important medical events that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. The number of participants who experienced an SAE is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Number of Participants Who Experienced a Serious Adverse Event (SAE)	3 Participants	6 Participants	4 Participants	5 Participants	5 Participants	9 Participants	4 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to approximately 18 months

Population: All participants who received ≥1 dose of study treatment

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	2 Participants	2 Participants	3 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 28 Days

Population: The DLT population included all participants who received ≥ 1 dose of study treatment and had follow-up through the DLT evaluation period (28 days on treatment) or who discontinued from study treatment due a to drug-related AE.

DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. A DLT was defined as any of the following events that occurs during the DLT evaluation period and is considered by the Investigator possibly, probably, or definitely related to bomedemstat: * A clinically significant bleeding event * Any Grade 4 or 5 non-haematologic adverse event * Any Grade 3 non-haematologic adverse event with failure to recover to Grade 1 within 7 days of drug cessation, with the following exceptions: ≥ Grade 3 nausea, vomiting or diarrhoea that responds to standard medical care and ≥ Grade 3 aesthenia lasting less than 14 days * Any Grade 3 electrolyte abnormality unrelated to the underlying malignancy and persisting greater than 24 hours. Per protocol, DLTs were measured during the first 28-day treatment period. The number of participants who experienced a DLT is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants who received ≥1 dose of study treatment

AEs were graded for severity on a scale of 1 to 5 using CTCAE criteria. Grade 1=mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2=moderate, minimal, local, or noninvasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3=severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care. Grade 4=life-threatening consequences with urgent intervention indicated. Grade 5 =death related to AE. The number of participants who experienced any Grade 3 to 5 AE is reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Number of Participants Experiencing Any Grade 3 to 5 Adverse Events (AE) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03	3 Participants	6 Participants	4 Participants	5 Participants	5 Participants	9 Participants	4 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants who received ≥1 dose of study treatment

Medical Events of Interest (MEOI) were adverse events that did not meet any criteria for a serious adverse event but were of particular interest in the context of the study. MEOIs included bleeding due to low platelets; electrocardiogram (ECG) QT corrected interval prolonged 481-500 milliseconds; and infection where, at a minimum, oral antibiotic, antifungal, or antiviral intervention is indicated. The number of participants with MEOIs is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Number of Participants Who Experienced a Medical Event of Interest (MEOI)	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1: predose and 1, 2, 3, and 24 hours postdose; Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone or administered with tretinoin and who had available data for the analysis of Cmax.

Cmax was defined as the maximum concentration of bomedemstat observed after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the CMax of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). Unbound plasma concentrations of bomedemstat were estimated by assuming that protein binding was 60.57%. For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the Cmax was determined for participants in Cohort 1. The LOQ of the assay was 1 ng/mL. The Cmax of bomedemstat in unbound plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Concentration (Cmax) of Bomedemstat Alone or Administered With Tretinoin Cycle 1 Day 1	10.7 nanograms/milliliter Standard Deviation 12.6	19.6 nanograms/milliliter Standard Deviation 19.0	65.7 nanograms/milliliter Standard Deviation 22.9	145 nanograms/milliliter Standard Deviation 85.5	66.8 nanograms/milliliter Standard Deviation 27.3	205 nanograms/milliliter Standard Deviation 112	—	—
Maximum Concentration (Cmax) of Bomedemstat Alone or Administered With Tretinoin Cycle 1 Day 7	9.67 nanograms/milliliter Standard Deviation 12.0	18.1 nanograms/milliliter Standard Deviation 10.4	72.2 nanograms/milliliter Standard Deviation 26.0	202 nanograms/milliliter Standard Deviation 111	119 nanograms/milliliter Standard Deviation 72.1	291 nanograms/milliliter Standard Deviation 211	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1: predose and 1, 2, 3, and 24 hours postdose; Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

Tmax was the time required to reach the maximum concentration of bomedemstat observed after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the TMax of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the Tmax was determined for participants in Cohort 1. The Tmax of bomedemstat in plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Time to Maximum Concentration (Tmax) of Bomedemstat Alone or Administered With Tretinoin Cycle 1 Day 1	1.00 hours Interval 0.93 to 3.0	2.00 hours Interval 0.93 to 3.05	1.00 hours Interval 0.92 to 2.08	2.06 hours Interval 1.0 to 3.03	1.00 hours Interval 0.92 to 1.17	1.02 hours Interval 0.97 to 2.5	—	—
Time to Maximum Concentration (Tmax) of Bomedemstat Alone or Administered With Tretinoin Cycle 1 Day 7	0.77 hours Interval 0.53 to 1.0	1.50 hours Interval 0.45 to 3.08	1.73 hours Interval 0.47 to 3.05	1.53 hours Interval 0.53 to 3.08	0.50 hours Interval 0.5 to 0.83	0.88 hours Interval 0.0 to 3.93	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1: predose and 1, 2, 3, and 24 hours postdose; Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

AUC0-24hr was defined as the total exposure of bomedemstat over 24 hours after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the AUC 0-24hr of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). Unbound plasma concentrations of bomedemstat were estimated by assuming that protein binding was 60.57%. For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the AUC 0-24hr was determined for participants in Cohort 1. The AUC 0-24hr of bomedemstat in unbound plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC0-24hr) Postdose of Bomedemstat Alone or Administered With Tretinoin Cycle 1 Day 1	26.4 hours●nanograms/milliliter Standard Deviation 39.2	78.6 hours●nanograms/milliliter Standard Deviation 36.8	323 hours●nanograms/milliliter Standard Deviation 142	1361 hours●nanograms/milliliter Standard Deviation 789	287 hours●nanograms/milliliter Standard Deviation 113	1138 hours●nanograms/milliliter Standard Deviation 621	—	—
Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC0-24hr) Postdose of Bomedemstat Alone or Administered With Tretinoin Cycle 1 Day 7	68.8 hours●nanograms/milliliter Standard Deviation 90.4	129 hours●nanograms/milliliter Standard Deviation 78.0	550 hours●nanograms/milliliter Standard Deviation 247	1361 hours●nanograms/milliliter Standard Deviation 747	383 hours●nanograms/milliliter Standard Deviation 116	1702 hours●nanograms/milliliter Standard Deviation 1326	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

t1/2 was the time required to divide the bomedemstat concentration by two after reaching pseudo-equilibrium after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the t1/2 of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the t1/2 was determined for participants in Cohort 1. The t1/2 of bomedemstat in plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=4 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=5 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Elimination Half Life (t1/2) of Bomedemstat Alone or Administered With Tretinoin	130 hours Standard Deviation NA Standard deviation could not be calculated for 1 participant	103 hours Standard Deviation 23.3	103 hours Standard Deviation 8.21	110 hours Standard Deviation 49.6	—	59.8 hours Standard Deviation 29.4	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

CL/F was the volume of plasma from which bomedemstat was eliminated per unit of time after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the CL/F of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the CL/F was determined for participants in Cohort 1. The CL/F of bomedemstat in plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=2 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Apparent Total Body Clearance (CL/F) of Bomedemstat Alone or Administered With Tretinoin	5.754 liters/hour Standard Deviation 7.711	1.351 liters/hour Standard Deviation 1.246	492 liters/hour Standard Deviation 322	401 liters/hour Standard Deviation 211	472 liters/hour Standard Deviation 88.3	287 liters/hour Standard Deviation 131	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

Vz/F was the volume of distribution of bomedemstat during the terminal phase after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the Vz/F of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the Vz/F was determined for participants in Cohort 1. The Vz/F of bomedemstat in plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=4 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=5 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Volume of Distribution (Vz/F) of Bomedemstat Alone or Administered With Tretinoin	56354 liters Standard Deviation NA Standard deviation could not be calculated for 1 participant	224527 liters Standard Deviation 122456	99822 liters Standard Deviation 74167	63895 liters Standard Deviation 24473	—	22539 liters Standard Deviation 6061	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 7: predose and 0.5, 1, 2, 3, 4, 8, and 24 hours postdose

kel was the rate at which bomedemstat was removed from the body by excretion or metabolism after administration of bomedemstat alone or administered with tretinoin. Plasma samples were collected at multiple time points to estimate the kel of bomedemstat using non-compartmental methods of analysis following oral dosing of participants in Cycle 1 (Cycle 1 = 7 days of treatment and 7 days of rest for a total of 14 days). kel was obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base e) concentration-time profiles. For the pharmacokinetic analysis, plasma concentrations below the assay limit of quantitation (LOQ) that occurred from predose to the first concentration ≥LOQ were treated as 0 and those that occured thereafter were treated as missing. The LOQ of the assay was 1 ng/mL. Per protocol, the kel was determined for participants in Cohort 1. The kel of bomedemstat in plasma is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=4 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=5 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Terminal Elimination Rate Constant (Kel) of Bomedemstat Alone or Administered With Tretinoin	0.0053 1/hour Standard Deviation NA Standard deviation could not be calculated for 1 participant	0.0071 1/hour Standard Deviation 0.0020	0.0068 1/hour Standard Deviation 0.0005	0.0074 1/hour Standard Deviation 0.0031	—	0.0135 1/hour Standard Deviation 0.0059	—	—

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk AML as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

EFS was defined as the time from the first dose of study treatment to the date of a documented EFS event of resistance, relapse, progression, or death due to any cause as assessed by the investigator. Participants without documented events were censored at the date of the last disease assessment. The EFS, calculated using the Kaplan-Meier method, is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=2 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Event-free Survival (EFS) For High-risk Acute Myeloid Leukemia (AML) Participants	0.87 Months Interval 0.8 to 0.93	0.97 Months Interval 0.93 to NA=Upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	0.93 Months Interval 0.9 to 18.81	2.46 Months Interval 0.97 to NA=Upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	0.93 Months Interval 0.93 to 3.96	NA Months Interval 0.5 to NA=Median and upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	1.43 Months Interval 1.4 to 1.46	0.93 Months Interval 0.47 to 5.59

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk MDS as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=1 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Event-free Survival (EFS) For High-risk Myelodysplastic Syndromes (MDS) Participants	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.	—	—	—	0.75 Months Interval 0.57 to 0.93	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.	—	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk AML as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

OS was defined as the time from the first dose of study treatment until death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The OS, calculated using the Kaplan-Meier method, is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=2 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Overall Survival (OS) For High-risk Acute Myeloid Leukemia (AML) Participants	NA Months Interval 0.8 to NA=Median and upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.	18.81 Months Interval 1.17 to 18.81	3.86 Months Interval 1.07 to NA=Upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 1.86 to NA=Median and upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 1.36 to NA=Median and upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 0.47 to NA=Median and upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk MDS as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=1 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Overall Survival (OS) For High-risk Myelodysplastic Syndromes (MDS) Participants	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.	—	—	—	NA Months Interval 0.57 to NA=Median and upper confidence interval not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.	—	NA Months NA=Median and lower and upper confidence intervals not reached at time of data cut-off due to insufficient number of participants with an event.

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk AML as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

ORR was the percentage of participants with a response of complete remission (CR), CR with incomplete recovery (Cri), morphologic leukaemia-free state (MLFS), partial remission (PR), cytogenetic CR (CRc), molecular CR (CRm), or stable disease (SD): * CR: \<5% bone marrow (BM) blasts or blasts with Auer rods; no extramedullary disease (EMD); absolute neutrophil count ≥1000/μL; platelets ≥100,000/μL; independent of transfusion * Cri: CR with residual neutropenia (\<1,000/μL) or thrombocytopenia (\<100,000/μL); no EMD; does not require transfusion independence (TI) * MLFS: \<5% blasts in BM with marrow spicules; no EMD; does not require TI * PR: ≥ 50% decrease in BM blasts to a range of 5%-25%; Neutrophils ≥ 1,000/μL; Platelets ≥ 100,000/μL; independent of transfusion. ≤ 5% blasts is PR if Auer rods present * CRc: CR+reversion to a normal karyotype if initially abnormal * CRm: CR+no evidence of residual disease by molecular testing * SD: No evidence of CR, PR, progression, new dysplastic changes

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=2 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Objective Response Rate (ORR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator	50.0 Percentage of participants Interval 1.3 to 98.7	16.7 Percentage of participants Interval 0.4 to 64.1	25.0 Percentage of participants Interval 0.6 to 80.6	50.0 Percentage of participants Interval 11.8 to 88.2	33.3 Percentage of participants Interval 0.8 to 90.6	28.6 Percentage of participants Interval 3.7 to 71.0	0.0 Percentage of participants NA=No participants achieved an objective response so the 95% confidence interval could not be calculated	28.6 Percentage of participants Interval 3.7 to 71.0

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk AML as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

BOR was the percentage of participants with a best overall response of CR, Cri, MLFS, PR, CRc, CRm, or SD: * CR: \<5% bone marrow (BM) blasts or blasts with Auer rods; no extramedullary disease (EMD); absolute neutrophil count ≥1000/μL; platelets ≥100,000/μL; independent of transfusion * Cri: CR with residual neutropenia (\<1,000/μL) or thrombocytopenia (\<100,000/μL); no EMD; does not require transfusion independence (TI) * MLFS: \<5% blasts in BM with marrow spicules; no EMD; does not require TI * PR: ≥ 50% decrease in BM blasts to a range of 5%-25%; Neutrophils ≥ 1,000/μL; Platelets ≥ 100,000/μL; independent of transfusion. ≤ 5% blasts is PR if Auer rods present * CRc: CR+reversion to a normal karyotype if initially abnormal * CRm: CR+no evidence of residual disease by molecular testing * SD: No evidence of CR, PR, progression, new dysplastic changes

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=2 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=3 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=7 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator Complete remission (CR)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator CR with incomplete recovery (CRi)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator Morphologic leukaemia-free state (MLFS)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator Partial remission (PR)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	14.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator Cytogenetic CR (CRc)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator Molecular CR (CRm)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Best Overall Response (BOR) For High-risk Acute Myeloid Leukemia (AML) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2003) and Assessed by the Investigator Stable disease (SD)	50.0 Percentage of participants	16.7 Percentage of participants	25.0 Percentage of participants	50.0 Percentage of participants	33.3 Percentage of participants	14.3 Percentage of participants	0.0 Percentage of participants	28.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk MDS as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

ORR was the percentage of participants with a response of complete remission (CR), partial remission (PR), marrow CR (CRm), cytogenetic response (CyR), or stable disease (SD) lasting for ≥4 weeks: * CR: ≤5% myeloblasts in the bone marrow (BM) with normal maturation of all cell lines; persistent dysplasia will be noted; Hgb ≥11 g/dL, Platelets ≥100 X 10\^9/L, Neutrophils ≥1.0 X 10\^9/L, and 0% Blasts in the peripheral blood * PR: All CR criteria if abnormal before treatment except: BM blasts decreased by ≥50% over pretreatment but still \>5%. Cellularity and morphology not relevant * CRm: ≤ 5% myeloblasts in BM and decrease by ≥50% over pretreatment. Hematological improvement responses in the peripheral blood will be noted in addition to bone marrow CR. * CyR: Complete=Disappearance of the chromosomal abnormality without appearance of new ones. Partial= ≥50% reduction of the chromosomal abnormality * SD: Failure to achieve at least PR, but no evidence of progression for \>8 weeks

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=1 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Objective Response Rate (ORR) For High-risk Myelodysplastic Syndromes (MDS) Participants Determined Using the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2006) and Assessed by the Investigator	100.0 Percentage of participants Interval 2.5 to 100.0	—	—	—	0.0 Percentage of participants NA=No participants achieved an objective response so the 95% confidence interval could not be calculated	0.0 Percentage of participants NA=No participants achieved an objective response so the 95% confidence interval could not be calculated	—	0.0 Percentage of participants NA=No participants achieved an objective response so the 95% confidence interval could not be calculated

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All participants with high-risk MDS as defined by the protocol, who received ≥1 dose of bomedemstat, had disease assessment at baseline, and had data available for the analysis.

BOR was the percentage of participants with a best overall response of CR, PR, CRm, CyR, or SD lasting for ≥4 weeks: * CR: ≤5% myeloblasts in the bone marrow (BM) with normal maturation of all cell lines; persistent dysplasia will be noted; Hgb ≥11 g/dL, Platelets ≥100 X 10\^9/L, Neutrophils ≥1.0 X 10\^9/L, and 0% Blasts in the peripheral blood * PR: All CR criteria if abnormal before treatment except: BM blasts decreased by ≥50% over pretreatment but still \>5%. Cellularity and morphology not relevant * CRm: ≤ 5% myeloblasts in BM and decrease by ≥50% over pretreatment. Hematological improvement responses in the peripheral blood will be noted in addition to bone marrow CR. * CyR: Complete=Disappearance of the chromosomal abnormality without appearance of new ones. Partial= ≥50% reduction of the chromosomal abnormality * SD: Failure to achieve at least PR, but no evidence of progression for \>8 weeks

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=1 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=2 Participants Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=1 Participants Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Best Overall Response (BOR) Assessed by the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2006): High-risk Myelodysplastic Syndromes (MDS) Participants Complete remission (CR)	0.0 Percentage of participants	—	—	—	0.0 Percentage of participants	0.0 Percentage of participants	—	0.0 Percentage of participants
Best Overall Response (BOR) Assessed by the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2006): High-risk Myelodysplastic Syndromes (MDS) Participants Partial remission (PR)	0.0 Percentage of participants	—	—	—	0.0 Percentage of participants	0.0 Percentage of participants	—	0.0 Percentage of participants
Best Overall Response (BOR) Assessed by the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2006): High-risk Myelodysplastic Syndromes (MDS) Participants Marrow CR (CRm)	0.0 Percentage of participants	—	—	—	0.0 Percentage of participants	0.0 Percentage of participants	—	0.0 Percentage of participants
Best Overall Response (BOR) Assessed by the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2006): High-risk Myelodysplastic Syndromes (MDS) Participants Cytogenetic response (CyR)	0.0 Percentage of participants	—	—	—	0.0 Percentage of participants	0.0 Percentage of participants	—	0.0 Percentage of participants
Best Overall Response (BOR) Assessed by the Revised/Modified International Working Group (IWG) Response Criteria (Cheson et al., 2006): High-risk Myelodysplastic Syndromes (MDS) Participants Stable disease (SD)	100.0 Percentage of participants	—	—	—	0.0 Percentage of participants	0.0 Percentage of participants	—	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study drug) and up to 28 days

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone and who had available data for the analysis.

Whole blood samples were collected at time intervals during the first 4 cycles (Cycle length = 7 days of treatment and 7 days of rest for a total of 14 days), which corresponds to 28 days on treatment. The percent change from baseline in erythrocyte count was measured. Baseline was the erythrocyte count at screening or the last available observation prior to the first dose of study drug. An analysis of treatment effect between the doses was determined using a Kruskal-Wallis test. This analysis was done to support the evaluation of plasma concentrations (Cmax and Cmin) and exposure (AUC) on haematopoiesis. Per protocol, the analysis was pre-specified to be done on participants that received bomedemstat alone. The maximum percent change from baseline in erythrocyte count is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Percent Change From Baseline Up to 28 Days of Treatment in Erythrocyte Count in Whole Blood After Administration of Bomedemstat	4.4 Percent change Standard Deviation 6.66	16.7 Percent change Standard Deviation 19.43	17.0 Percent change Standard Deviation 5.83	21.4 Percent change Standard Deviation 14.97	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study drug) and up to 28 days

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone and who had available data for the analysis.

Whole blood samples were collected at time intervals during the first 4 cycles (Cycle length = 7 days of treatment and 7 days of rest for a total of 14 days), which corresponds to 28 days on treatment. The percent change from baseline in neutrophil count was measured. Baseline was the neutrophil count at screening or the last available observation prior to the first dose of study drug. An analysis of treatment effect between the doses was determined using a Kruskal-Wallis test. This analysis was done to support the evaluation of plasma concentrations (Cmax and Cmin) and exposure (AUC) on haematopoiesis. Per protocol, the analysis was pre-specified to be done on participants that received bomedemstat alone. The maximum percent change from baseline in neutrophil count is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=3 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Percent Change From Baseline Up to 28 Days of Treatment in Neutrophil Count in Whole Blood After Administration of Bomedemstat	198.4 Percent change Standard Deviation 206.33	223.3 Percent change Standard Deviation 259.61	198.8 Percent change Standard Deviation 273.54	3218.0 Percent change Standard Deviation 7780.65	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study drug) and up to 28 days

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone and who had available data for the analysis.

Whole blood samples were collected at time intervals during the first 4 cycles (Cycle length = 7 days of treatment and 7 days of rest for a total of 14 days), which corresponds to 28 days on treatment. The percent change from baseline in platelet count was measured. Baseline was the platelet count at screening or the last available observation prior to the first dose of study drug. An analysis of treatment effect between the doses was determined using a Kruskal-Wallis test. This analysis was done to support the evaluation of plasma concentrations (Cmax and Cmin) and exposure (AUC) on haematopoiesis. Per protocol, the analysis was pre-specified to be done on participants that received bomedemstat alone. The maximum percent change from baseline in platelet count is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Percent Change From Baseline Up to 28 Days of Treatment in Platelet Count in Whole Blood After Administration of Bomedemstat	21.9 Percent change Standard Deviation 18.15	30.4 Percent change Standard Deviation 73.39	313.6 Percent change Standard Deviation 529.94	8.1 Percent change Standard Deviation 20.79	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study drug) and up to 28 days

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone and who had available data for the analysis.

Whole blood samples were collected at time intervals during the first 4 cycles (Cycle length = 7 days of treatment and 7 days of rest for a total of 14 days), which corresponds to 28 days on treatment. The percent change from baseline in reticulocyte count was measured. Baseline was the reticulocyte count at screening or the last available observation prior to the first dose of study drug. An analysis of treatment effect between the doses was determined using a Kruskal-Wallis test. This analysis was done to support the evaluation of plasma concentrations (Cmax and Cmin) and exposure (AUC) on haematopoiesis. Per protocol, the analysis was pre-specified to be done on participants that received bomedemstat alone. The maximum percent change from baseline in reticulocyte count is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=5 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Percent Change From Baseline Up to 28 Days of Treatment in Reticulocyte Count in Whole Blood After Administration of Bomedemstat	47.3 Percent change Standard Deviation 102.51	57.1 Percent change Standard Deviation 52.48	133.5 Percent change Standard Deviation 158.03	26.6 Percent change Standard Deviation 51.64	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study drug) and up to 28 days

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone and who had available data for the analysis.

Whole blood samples were collected at time intervals during the first 4 cycles (Cycle length = 7 days of treatment and 7 days of rest for a total of 14 days), which corresponds to 28 days on treatment. The percent change from baseline in the number of blasts was measured. Baseline was the number of blasts at screening or the last available observation prior to the first dose of study drug. An analysis of treatment effect between the doses was determined using a Kruskal-Wallis test. This analysis was done to support the evaluation of plasma concentrations (Cmax and Cmin) and exposure (AUC) on haematopoiesis. Per protocol, the analysis was pre-specified to be done on participants that received bomedemstat alone. The maximum percent change from baseline in the number of blasts is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=4 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=3 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Percent Change From Baseline Up to 28 Days of Treatment in The Number of Blasts in Whole Blood After Administration of Bomedemstat	368.0 Percent change Standard Deviation 399.54	2478.3 Percent change Standard Deviation 3278.96	9.7 Percent change Standard Deviation 25.23	2841.4 Percent change Standard Deviation 6046.61	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study drug) and up to 28 days

Population: The analysis population consisted of all participants from Cohort 1 who received ≥1 dose of bomedemstat alone and who had available data for the analysis.

Whole blood samples were collected at time intervals during the first 4 cycles (Cycle length = 7 days of treatment and 7 days of rest for a total of 14 days), which corresponds to 28 days on treatment. The percent change from baseline in the hemoglobin level was measured. Baseline was the hemoglobin level at screening or the last available observation prior to the first dose of study drug. An analysis of treatment effect between the doses was determined using a Kruskal-Wallis test. This analysis was done to support the evaluation of plasma concentrations (Cmax and Cmin) and exposure (AUC) on haematopoiesis. Per protocol, the analysis was pre-specified to be done on participants that received bomedemstat alone. The maximum percent change from baseline in hemoglobin level is presented.

Outcome measures

Outcome measures
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 Participants Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 Participants Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 Participants Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 Participants Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Maximum Percent Change From Baseline Up to 28 Days of Treatment in Hemoglobin Level in Whole Blood After Administration of Bomedemstat	1262.1 Percent change Standard Deviation 429.99	476.5 Percent change Standard Deviation 710.28	12.6 Percent change Standard Deviation 3.76	134.4 Percent change Standard Deviation 296.96	—	—	—	—

Adverse Events

Cohort 1a: Bomedemstat 0.75 mg/kg/Day

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Cohort 1b: Bomedemstat 1.5 mg/kg/Day

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 1c: Bomedemstat 3 mg/kg/Day

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

Cohort 1d: Bomedemstat 6 mg/kg/Day

Serious events: 5 serious events

Other events: 6 other events

Deaths: 3 deaths

Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day

Serious events: 9 serious events

Other events: 9 other events

Deaths: 2 deaths

Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day

Serious events: 8 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 participants at risk Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 participants at risk Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 participants at risk Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 participants at risk Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 participants at risk Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 participants at risk Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 participants at risk Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 participants at risk Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 7 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 4/6 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	44.4% 4/9 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 4/8 • Number of events 7 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Atrioventricular block complete	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Ear and labyrinth disorders Ear pain	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Fatigue	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Malaise	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Abscess neck	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Bacterial sepsis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Catheter site infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Cellulitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Conjunctivitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Device related infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Diverticulitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Enterobacter bacteraemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Enterococcal bacteraemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Epiglottitis	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Escherichia infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Eye infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Folliculitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Infection	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Influenza	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Klebsiella sepsis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Lower respiratory tract infection fungal	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Neutropenic sepsis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Oral infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Otitis externa	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Pantoea agglomerans infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Periorbital cellulitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Periorbital infection	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Pharyngeal abscess	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Pneumonia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Sepsis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Urosepsis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Subdural haemorrhage	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Pulmonary function test decreased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia cutis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Headache	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Syncope	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Acute promyelocytic leukaemia differentiation syndrome	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Haematoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.

Other adverse events

Other adverse events
Measure	Cohort 1a: Bomedemstat 0.75 mg/kg/Day n=3 participants at risk Participants received bomedemstat 0.75 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1b: Bomedemstat 1.5 mg/kg/Day n=6 participants at risk Participants received bomedemstat 1.5 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1c: Bomedemstat 3 mg/kg/Day n=4 participants at risk Participants received bomedemstat 3 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1d: Bomedemstat 6 mg/kg/Day n=6 participants at risk Participants received bomedemstat 6 mg/kg/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day n=5 participants at risk Participants received bomedemstat 3 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=9 participants at risk Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 14-day cycles consisting of 7 days of treatment and 7 days of rest. Participants received up to 4 cycles (14-day cycles) for up to a total of up 56 days (28 days on treatment).	Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=4 participants at risk Participants received bomedemstat 6 mg/kg/day orally plus tretinoin 45 mg/m\^2/day orally in 21-day cycles consisting of 14 days of treatment and 7 days of rest. Participants received up to 2 cycles (21-day cycles) for up to a total of up 42 days (28 days on treatment).	Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day n=8 participants at risk Participants received bomedemstat 6 mg/kg/day orally for 21 days plus tretinoin 45 mg/m\^2/day orally in 28-day cycles consisting of 21 days of treatment and 7 days of rest. Participants received at least 1 cycle (28-day cycles) and received subsequent cycles at the discretion of the investigator.
General disorders Malaise	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Localised oedema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	44.4% 4/9 • Number of events 7 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Lymphadenopathy	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Splenic infarction	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 3/3 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 4/6 • Number of events 10 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Atrial flutter	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Atrial tachycardia	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Cardiac disorders Tachycardia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Congenital, familial and genetic disorders Macroglossia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Ear and labyrinth disorders Ear discomfort	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Ear and labyrinth disorders Ear pain	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Conjunctival hyperaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Conjunctival oedema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Dacryostenosis acquired	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Dry eye	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Ectropion	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Eye discharge	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Eye haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Eye pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Eye swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Ocular hyperaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Periorbital disorder	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Eye disorders Vision blurred	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Angina bullosa haemorrhagica	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Chapped lips	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 4/6 • Number of events 7 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	100.0% 4/4 • Number of events 10 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 6/9 • Number of events 11 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	100.0% 4/4 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	87.5% 7/8 • Number of events 10 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Enteritis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Epiploic appendagitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Glossitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Lip dry	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Melaena	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 7 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Mouth ulceration	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	83.3% 5/6 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	77.8% 7/9 • Number of events 9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	62.5% 5/8 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Oral mucosa haematoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Oral pain	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Palatal ulcer	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Perianal erythema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Tongue discomfort	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Tongue ulceration	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Toothache	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Umbilical hernia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 4/6 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	44.4% 4/9 • Number of events 8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	62.5% 5/8 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Application site irritation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Application site laceration	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Asthenia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Catheter site erythema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Catheter site haematoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Catheter site pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Catheter site swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Chest pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Device related thrombosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Fatigue	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders General physical health deterioration	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Injection site swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Local swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Mucosal haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Product Issues Thrombosis in device	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Oedema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 4/6 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	44.4% 4/9 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	62.5% 5/8 • Number of events 10 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Peripheral swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Suprapubic pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Thirst	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
General disorders Vessel puncture site bruise	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Hepatobiliary disorders Hepatomegaly	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Immune system disorders Drug hypersensitivity	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Abscess neck	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Acute haemorrhagic conjunctivitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Catheter site infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Cellulitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Conjunctivitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Transfusion reaction	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Device related infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Diverticulitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Ear infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Escherichia urinary tract infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Folliculitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Furuncle	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Herpes simplex	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Herpes simplex oesophagitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Hordeolum	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Infected skin ulcer	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Klebsiella bacteraemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Localised infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Onychomycosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Oral candidiasis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Oral herpes	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Osteomyelitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Otitis externa	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Periorbital cellulitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Periorbital infection	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Pneumonia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Pneumonia klebsiella	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Pulmonary mycosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Rhinitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Sepsis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Infections and infestations Wound infection	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Chest injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Contusion	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Excoriation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Face injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Genital injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Laceration	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Lip injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Post procedural contusion	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Procedural pain	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Injury, poisoning and procedural complications Vulval laceration	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Antiphospholipid antibodies positive	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Blood bilirubin increased	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Blood creatinine increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Blood glucose fluctuation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Blood urine present	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Body temperature increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Breath sounds abnormal	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations C-reactive protein increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Cardiac murmur	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Coma scale abnormal	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Inspiratory capacity decreased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations International normalised ratio increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Liver function test abnormal	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Occult blood positive	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Urinary casts	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations Weight decreased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Investigations White blood cell count increased	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	75.0% 3/4 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Agitation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Fluid overload	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Gout	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 6/9 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	100.0% 4/4 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 6/9 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	66.7% 6/9 • Number of events 7 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Magnesium deficiency	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Groin pain	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Inguinal mass	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia cutis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Ageusia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Balance disorder	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Complex regional pain syndrome	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Dizziness	66.7% 2/3 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	40.0% 2/5 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Dyskinesia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Hemiparesis	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Lethargy	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Myoclonus	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Presyncope	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Spinal cord oedema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Nervous system disorders Tremor	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Anxiety	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Confusional state	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Delirium	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Depressed mood	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Hallucination	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Hallucination, visual	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Bladder spasm	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Dysuria	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Haematuria	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Reproductive system and breast disorders Breast mass	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Reproductive system and breast disorders Penile pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Reproductive system and breast disorders Testicular pain	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Acute promyelocytic leukaemia differentiation syndrome	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	44.4% 4/9 • Number of events 6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 3/9 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Nasal mucosal erosion	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	66.7% 2/3 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Rales	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Acne	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Actinic keratosis	33.3% 1/3 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Nail hypertrophy	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Petechiae	33.3% 1/3 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	37.5% 3/8 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 2/8 • Number of events 5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	11.1% 1/9 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Splinter haemorrhages	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Axillary vein thrombosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Extremity necrosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Haematoma	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Hypertension	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	22.2% 2/9 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	25.0% 1/4 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	33.3% 2/6 • Number of events 3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 3/6 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	20.0% 1/5 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	44.4% 4/9 • Number of events 4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	50.0% 2/4 • Number of events 2 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Jugular vein thrombosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Pallor	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Thrombophlebitis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	12.5% 1/8 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.
Vascular disorders Venous thrombosis	0.00% 0/3 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	16.7% 1/6 • Number of events 1 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/6 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/5 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/9 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/4 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.	0.00% 0/8 • Up to approximately 24 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment. Progression of underlying malignancy was not reported as an AE if it is consistent with the suspected progression of the underlying cancer.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Lead/Coordinating Investigator will have the right to submit for publication any results arising from the study subject to the terms and conditions of the Clinical Trial and Confidentiality Disclosure Agreements.
Publication restrictions are in place

Restriction type: OTHER