Trial Outcomes & Findings for A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) (NCT NCT05104866)

Last Updated: 2026-05-05

Results Overview

PFS is defined as time from randomization until progression per RECIST 1.1, as assessed by BICR, or death due to any cause. The analysis will include all randomized participants as randomized regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

732 participants

Primary outcome timeframe

On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months

Results posted on

2026-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Investigator's Choice of Chemotherapy (ICC) Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)	Dato-DXd Arm 1: Dato-DXd
Overall Study STARTED	367	365
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	367	365

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigator's Choice of Chemotherapy (ICC) Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)	Dato-DXd Arm 1: Dato-DXd
Overall Study Reason unknown	1	1
Overall Study Ongoing in study at data cut-off date	131	120
Overall Study Withdrawal by Subject	29	25
Overall Study Lost to Follow-up	2	5
Overall Study Death	204	214

Baseline Characteristics

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)	Total n=732 Participants Total of all reporting groups
Age, Continuous	56.0 Years n=54 Participants	54.0 Years n=60 Participants	55.0 Years n=114 Participants
Sex: Female, Male Female	360 Participants n=54 Participants	363 Participants n=60 Participants	723 Participants n=114 Participants
Sex: Female, Male Male	5 Participants n=54 Participants	4 Participants n=60 Participants	9 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=54 Participants	43 Participants n=60 Participants	83 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	322 Participants n=54 Participants	318 Participants n=60 Participants	640 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=54 Participants	6 Participants n=60 Participants	9 Participants n=114 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=54 Participants	7 Participants n=60 Participants	11 Participants n=114 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race/Ethnicity, Customized Asian	146 Participants n=54 Participants	152 Participants n=60 Participants	298 Participants n=114 Participants
Race/Ethnicity, Customized White	180 Participants n=54 Participants	170 Participants n=60 Participants	350 Participants n=114 Participants
Race/Ethnicity, Customized Other	3 Participants n=54 Participants	6 Participants n=60 Participants	9 Participants n=114 Participants
Race/Ethnicity, Customized Not reported	32 Participants n=54 Participants	32 Participants n=60 Participants	64 Participants n=114 Participants

PRIMARY outcome

Timeframe: On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Progression-Free Survival	6.9 Months Interval 5.7 to 7.4	4.9 Months Interval 4.2 to 5.5

PRIMARY outcome

Timeframe: From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.

OS is defined as time from randomization until the date of death due to any cause. The comparison will include all randomized participants as randomized, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the hazard ratio of OS.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Overall Survival	18.6 Months Interval 17.3 to 20.1	18.3 Months Interval 17.3 to 20.5

SECONDARY outcome

Timeframe: From date of randomization until event. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months for investigator assessment.

Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Objective Response Rate (ORR) Confirmed response by BICR assessment based on IA1 data cut-off Raw Response Rate (%)	36.44 percentage of participants Interval 31.49 to 41.61	22.89 percentage of participants Interval 18.69 to 27.53
Objective Response Rate (ORR) Confirmed response by investigator assessment based on FA data cut-off Raw Response Rate (%)	36.71 percentage of participants Interval 31.76 to 41.89	22.07 percentage of participants Interval 17.93 to 26.67

SECONDARY outcome

Timeframe: From date of first response until progression or death. Tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months.

Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR assessment or death due to any cause.

Outcome measures

Outcome measures
Measure	Dato-DXd n=133 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=84 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Duration of Response (DoR) as Assessed by BICR Assessment	6.7 Months Interval 5.6 to 9.8	5.7 Months Interval 4.9 to 6.8

SECONDARY outcome

Duration of response is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by Investigator assessment or death due to any cause.

Outcome measures

Outcome measures
Measure	Dato-DXd n=134 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=81 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Duration of Response (DoR) as Assessed by Investigator Assessment	7.2 Months Interval 5.7 to 8.6	6.0 Months Interval 4.7 to 7.7

SECONDARY outcome

Timeframe: On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months

PFS by Investigator assessment will be defined as the time from the date of randomization until the date of PD per RECIST 1.1 (by Investigator assessment) or death (by any cause in the absence of progression), (ie, date of event or censoring - date of randomization + 1).

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Progression-Free Survival by Investigator Assessment	6.9 Months Interval 5.9 to 7.2	4.5 Months Interval 4.2 to 5.5

SECONDARY outcome

Timeframe: Assessed up to data cut-off (17Jul2023) to a maximum of 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of 33 months for investigator assessment.

DCR is defined as the percentage of participants who have a confirmed CR or PR up to data cut-off date or who have SD for at least 11 weeks after randomization, per RECIST 1.1, as assessed BICR/per investigator assessment and derived from the raw tumor data.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Disease Control Rate (DCR) Response by investigator assessment based on FA data cut-off Raw disease control rate (%)	80.82 percentage of participants Interval 76.4 to 84.73	66.76 percentage of participants Interval 61.68 to 71.56
Disease Control Rate (DCR) Response by BICR assessment based on IA1 data cut-off Raw disease control rate (%)	75.34 percentage of participants Interval 70.59 to 79.68	63.76 percentage of participants Interval 58.61 to 68.69

SECONDARY outcome

Timeframe: From randomization to start of first subsequent anti-cancer therapy. Assessments occur at every visit after study treatment has been discontinued. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.

Time to first subsequent therapy is defined as the time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Time to First Subsequent Therapy (TFST)	8.0 Months Interval 7.2 to 8.8	5.2 Months Interval 4.6 to 5.8

SECONDARY outcome

Timeframe: From randomization to start of second subsequent anti-cancer therapy. Assessments occur at every visit after study treatment has been discontinued. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.

Time to second subsequent therapy is defined as the time from randomization to until the start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Time to Second Subsequent Therapy (TSST)	13.7 Months Interval 12.4 to 15.0	12.3 Months Interval 10.8 to 13.7

SECONDARY outcome

Timeframe: From date of randomization to second progression or death. PFS2 assessments occur every 3 months after disease progression. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months

Time to second progression of death will be defined as the time from the randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy, or death. The date of second progression will be recorded by the Investigator in the eCRF and defined according to local standard clinical practice.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Time From Randomization to Second Progression or Death (PFS2)	11.7 Months Interval 10.8 to 13.1	10.4 Months Interval 9.6 to 11.5

SECONDARY outcome

Timeframe: From date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.

Time to deterioration in pain as measured by the pain scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 increase in score relative to baseline score

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Clinical Outcome Assessment- TTD in Pain	3.5 Months Interval 2.8 to 5.0	2.8 Months Interval 2.1 to 3.4

SECONDARY outcome

Time to deterioration in physical functioning as measured by the physical functioning scale from EORTC QLQ-C30. Deterioration is defined as a 13.3 decrease in score relative to baseline score.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Clinical Outcome Assessment- TTD in Physical Functioning	5.6 Months Interval 3.5 to 9.7	3.5 Months Interval 2.2 to 4.9

SECONDARY outcome

Time to deterioration in global health status/QoL as measured by the global health status/QoL scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 decrease in score relative to baseline score.

Outcome measures

Outcome measures
Measure	Dato-DXd n=365 Participants Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=367 Participants Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Clinical Outcome Assessment- TTD in GHS	3.4 Months Interval 2.1 to 5.0	2.1 Months Interval 1.5 to 2.9

Adverse Events

Dato-DXd

Serious events: 62 serious events

Other events: 348 other events

Deaths: 223 deaths

Investigator's Choice of Chemotherapy (ICC)

Serious events: 67 serious events

Other events: 329 other events

Deaths: 213 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Dato-DXd n=360 participants at risk Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=351 participants at risk Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Cardiac disorders Palpitations	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Nausea	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Cardiac disorders Cardiac failure	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.57% 2/351 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Dizziness postural	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Epilepsy	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Hemiparesis	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Seizure	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Syncope	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Psychiatric disorders Suicidal ideation	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Renal and urinary disorders Acute kidney injury	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Renal and urinary disorders Chronic kidney disease	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Renal and urinary disorders Renal impairment	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Asthma	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Platelet count decreased	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.57% 2/351 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.85% 3/351 • Number of events 3 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Cardiac disorders Supraventricular tachycardia	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.83% 3/360 • Number of events 3 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.57% 2/351 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Skin and subcutaneous tissue disorders Angioedema	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Vascular disorders Embolism	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Endocrine disorders Hypercalcaemia of malignancy	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Endocrine disorders Thyroiditis subacute	0.28% 1/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Cataract	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Blood and lymphatic system disorders Anaemia	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Punctate keratitis	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Retinal tear	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Abdominal pain	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Diarrhoea	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Gastric mucosal lesion	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Ileus	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Lip blister	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.00% 0/351 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Neutropenic colitis	0.00% 0/360 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Stomatitis	0.28% 1/360 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Vomiting	0.56% 2/360 • Number of events 2 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.28% 1/351 • Number of events 1 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)

Other adverse events
Measure	Dato-DXd n=360 participants at risk Arm 1: Dato-DXd	Investigator's Choice of Chemotherapy (ICC) n=351 participants at risk Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)
Respiratory, thoracic and mediastinal disorders Cough	13.6% 49/360 • Number of events 58 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	9.4% 33/351 • Number of events 36 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.2% 15/360 • Number of events 16 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	6.3% 22/351 • Number of events 23 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Nausea	56.7% 204/360 • Number of events 326 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	27.1% 95/351 • Number of events 126 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Dysgeusia	5.3% 19/360 • Number of events 21 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	4.0% 14/351 • Number of events 14 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Headache	8.3% 30/360 • Number of events 35 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	10.8% 38/351 • Number of events 46 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Neuropathy peripheral	1.7% 6/360 • Number of events 6 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	6.8% 24/351 • Number of events 28 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Nervous system disorders Paraesthesia	2.8% 10/360 • Number of events 10 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	6.0% 21/351 • Number of events 26 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 22/360 • Number of events 36 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	1.7% 6/351 • Number of events 6 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Skin and subcutaneous tissue disorders Alopecia	37.8% 136/360 • Number of events 139 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	22.8% 80/351 • Number of events 80 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Skin and subcutaneous tissue disorders Dry skin	6.4% 23/360 • Number of events 23 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	1.7% 6/351 • Number of events 6 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	2.5% 9/360 • Number of events 9 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	12.8% 45/351 • Number of events 52 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Skin and subcutaneous tissue disorders Pruritus	8.9% 32/360 • Number of events 37 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	2.0% 7/351 • Number of events 8 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Skin and subcutaneous tissue disorders Rash	9.4% 34/360 • Number of events 35 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	2.8% 10/351 • Number of events 11 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Blepharitis	7.8% 28/360 • Number of events 28 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	1.7% 6/351 • Number of events 7 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Dry eye	26.9% 97/360 • Number of events 107 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	13.1% 46/351 • Number of events 47 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Keratitis	8.3% 30/360 • Number of events 37 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	2.8% 10/351 • Number of events 15 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Lacrimation increased	7.8% 28/360 • Number of events 29 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	0.85% 3/351 • Number of events 3 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Blood and lymphatic system disorders Anaemia	17.2% 62/360 • Number of events 78 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	24.5% 86/351 • Number of events 134 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Meibomian gland dysfunction	6.9% 25/360 • Number of events 27 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	1.7% 6/351 • Number of events 6 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Eye disorders Punctate keratitis	11.9% 43/360 • Number of events 53 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	6.6% 23/351 • Number of events 26 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Abdominal pain	6.9% 25/360 • Number of events 28 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	8.5% 30/351 • Number of events 33 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Constipation	35.0% 126/360 • Number of events 161 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	17.1% 60/351 • Number of events 70 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Diarrhoea	11.4% 41/360 • Number of events 59 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	19.1% 67/351 • Number of events 95 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Dry mouth	5.8% 21/360 • Number of events 32 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	1.7% 6/351 • Number of events 6 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Stomatitis	52.2% 188/360 • Number of events 300 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	14.0% 49/351 • Number of events 58 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Gastrointestinal disorders Vomiting	23.9% 86/360 • Number of events 118 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	11.7% 41/351 • Number of events 59 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
General disorders Asthenia	15.6% 56/360 • Number of events 97 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	17.4% 61/351 • Number of events 72 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
General disorders Fatigue	28.3% 102/360 • Number of events 117 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	20.2% 71/351 • Number of events 80 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
General disorders Pyrexia	8.1% 29/360 • Number of events 33 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	10.8% 38/351 • Number of events 52 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Blood and lymphatic system disorders Leukopenia	3.6% 13/360 • Number of events 25 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	8.3% 29/351 • Number of events 61 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Infections and infestations Covid-19	19.4% 70/360 • Number of events 75 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	14.2% 50/351 • Number of events 51 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Infections and infestations Upper respiratory tract infection	5.8% 21/360 • Number of events 25 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	5.4% 19/351 • Number of events 20 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Infections and infestations Urinary tract infection	6.7% 24/360 • Number of events 31 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	5.1% 18/351 • Number of events 20 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Blood and lymphatic system disorders Neutropenia	5.8% 21/360 • Number of events 29 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	25.9% 91/351 • Number of events 194 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Alanine aminotransferase increased	10.6% 38/360 • Number of events 50 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	14.2% 50/351 • Number of events 68 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Aspartate aminotransferase increased	16.9% 61/360 • Number of events 78 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	16.8% 59/351 • Number of events 80 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Blood alkaline phosphatase increased	6.1% 22/360 • Number of events 28 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	4.6% 16/351 • Number of events 24 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Neutrophil count decreased	6.9% 25/360 • Number of events 58 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	21.4% 75/351 • Number of events 205 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Platelet count decreased	2.5% 9/360 • Number of events 11 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	5.1% 18/351 • Number of events 28 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)
Investigations Weight decreased	8.6% 31/360 • Number of events 32 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)	4.6% 16/351 • Number of events 17 • Adverse Event data was collected from time of signature of informed consent until the follow-up period is completed (35 days after the last dose of study treatment) (maximum duration of approximately 28 months). All-Cause Mortality was assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months. All-Cause Mortality was assessed in the Full Analysis Set (all randomised participants). Serious and Other adverse events were assessed in the Safety Analysis Population (all treated subjects)