Trial Outcomes & Findings for Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) (NCT NCT04656652)

Last Updated: 2026-02-05

Results Overview

PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

605 participants

Primary outcome timeframe

From randomization until disease progression or death (whichever occurs first), up to approximately 27 months

Results posted on

2026-02-05

Participant Flow

A total of 605 participants , including 1 participant who was randomized twice, were randomized to the study in Europe, Asia, North America, South America, and Australia.

Participant milestones

Participant milestones
Measure	DS-1062a 6.0 mg/kg Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 Participants were randomized to receive 75 mg/m\^2 docetaxel.
Overall Study STARTED	299	305
Overall Study COMPLETED	68	62
Overall Study NOT COMPLETED	231	243

Reasons for withdrawal

Reasons for withdrawal
Measure	DS-1062a 6.0 mg/kg Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 Participants were randomized to receive 75 mg/m\^2 docetaxel.
Overall Study Lost to Follow-up	2	2
Overall Study Death	213	212
Overall Study Other	1	0
Overall Study Withdrawal by Subject	15	29

Baseline Characteristics

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DS-1062a 6.0 mg/kg n=299 Participants Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=305 Participants Participants were randomized to receive 75 mg/m\^2 docetaxel.	Total n=604 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	162 Participants n=25 Participants	155 Participants n=26 Participants	317 Participants n=51 Participants
Age, Categorical >=65 years	137 Participants n=25 Participants	150 Participants n=26 Participants	287 Participants n=51 Participants
Age, Continuous	62.7 years STANDARD_DEVIATION 9.09 • n=25 Participants	62.6 years STANDARD_DEVIATION 10.28 • n=26 Participants	62.6 years STANDARD_DEVIATION 9.7 • n=51 Participants
Sex: Female, Male Female	116 Participants n=25 Participants	95 Participants n=26 Participants	211 Participants n=51 Participants
Sex: Female, Male Male	183 Participants n=25 Participants	210 Participants n=26 Participants	393 Participants n=51 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants
Race/Ethnicity, Customized Asian	121 Participants n=25 Participants	120 Participants n=26 Participants	241 Participants n=51 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=25 Participants	4 Participants n=26 Participants	10 Participants n=51 Participants
Race/Ethnicity, Customized White	123 Participants n=25 Participants	126 Participants n=26 Participants	249 Participants n=51 Participants
Race/Ethnicity, Customized Other	42 Participants n=25 Participants	47 Participants n=26 Participants	89 Participants n=51 Participants
Race/Ethnicity, Customized Unknown or Not Reported	6 Participants n=25 Participants	8 Participants n=26 Participants	14 Participants n=51 Participants

PRIMARY outcome

Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 27 months

Population: Full Analysis Set includes all randomized subjects. If a subject was randomized more than once, only one of the participants is included in the Full Analysis Set.

PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.

Outcome measures

Outcome measures
Measure	DS-1062a 6.0 mg/kg n=299 Participants Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=305 Participants Participants were randomized to receive 75 mg/m\^2 docetaxel.
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel	4.4 months Interval 4.2 to 5.6	3.7 months Interval 2.9 to 4.2

PRIMARY outcome

Timeframe: From randomization until date of death due to any cause, up to to approximately 38 months

Population: Full Analysis Set includes all randomized subjects. If a subject was randomized more than once, only one of the participants is included in the Full Analysis Set.

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

Outcome measures

Outcome measures
Measure	DS-1062a 6.0 mg/kg n=299 Participants Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=305 Participants Participants were randomized to receive 75 mg/m\^2 docetaxel.
Overall Survival (OS) Following DS-1062a Versus Docetaxel	12.9 months Standard Deviation 11.0	11.8 months Standard Deviation 10.1

SECONDARY outcome

Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.

Outcome measures

Outcome measures
Measure	DS-1062a 6.0 mg/kg n=299 Participants Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=305 Participants Participants were randomized to receive 75 mg/m\^2 docetaxel.
Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel	4.4 months Interval 4.2 to 5.5	3.0 months Interval 2.8 to 4.0

SECONDARY outcome

Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

ORR is defined as the proportion of subjects who achieved a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by BICR and investigator per RECIST v1.1.

Outcome measures

Outcome measures
Measure	DS-1062a 6.0 mg/kg n=299 Participants Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=305 Participants Participants were randomized to receive 75 mg/m\^2 docetaxel.
Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Assessed by Blinded Independent Central Review	79 Participants	39 Participants
Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Assessed by Investigator	74 Participants	44 Participants

SECONDARY outcome

Timeframe: From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months

Population: Full Analysis Set includes all randomized subjects. If a subject was randomized more than once, only one of the participants is included in the Full Analysis Set.

DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic Progressive Disease or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	DS-1062a 6.0 mg/kg n=299 Participants Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=305 Participants Participants were randomized to receive 75 mg/m\^2 docetaxel.
Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Assessed by Blinded Independent Central Review	7.1 months Interval 5.6 to 10.9	5.6 months Interval 5.4 to 8.1
Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel Assessed by Investigator	9.6 months Interval 6.7 to 11.1	6.4 months Interval 5.1 to 8.3

Adverse Events

DS-1062a 6.0 mg/kg

Serious events: 92 serious events

Other events: 273 other events

Deaths: 215 deaths

Docetaxel 75 mg/m^2

Serious events: 111 serious events

Other events: 262 other events

Deaths: 218 deaths

Serious adverse events

Other adverse events

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	DS-1062a 6.0 mg/kg n=297 participants at risk Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=290 participants at risk Participants were randomized to receive 75 mg/m\^2 docetaxel.
Blood and lymphatic system disorders Anaemia	1.0% 3/297 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Blood and lymphatic system disorders Febrile neutropenia	0.67% 2/297 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	3.8% 11/290 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.69% 2/290 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Blood and lymphatic system disorders Neutropenia	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Blood and lymphatic system disorders Pancytopenia	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Atrial fibrillation	0.67% 2/297 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Cardiac arrest	0.67% 2/297 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Cardiac tamponade	0.67% 2/297 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Cardio-respiratory arrest	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Coronary artery stenosis	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Palpitations	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Pericardial effusion	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Cardiac disorders Supraventricular tachycardia	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Endocrine disorders Hypercalcaemia of malignancy	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Keratitis	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Rhegmatogenous retinal detachment	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Ulcerative keratitis	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Vision blurred	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Visual acuity reduced	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Abdominal pain upper	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Colitis	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Enterocolitis	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.69% 2/290 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Melaena	0.34% 1/297 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Nausea	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Oesophagitis	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Rectal haemorrhage	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Stomatitis	1.7% 5/297 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Vomiting	1.0% 3/297 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Asthenia	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Chest pain	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Death	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.69% 2/290 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Disease progression	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Fatigue	0.00% 0/297 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.69% 2/290 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders General physical health deterioration	0.67% 2/297 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.34% 1/290 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Malaise	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Mucosal inflammation	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Multiple organ dysfunction syndrome	0.34% 1/297 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	0.00% 0/290 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.

Other adverse events
Measure	DS-1062a 6.0 mg/kg n=297 participants at risk Participants were randomized to receive 6.0 mg/kg of DS-1062a.	Docetaxel 75 mg/m^2 n=290 participants at risk Participants were randomized to receive 75 mg/m\^2 docetaxel.
Blood and lymphatic system disorders Anaemia	16.8% 50/297 • Number of events 90 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	24.8% 72/290 • Number of events 140 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Blood and lymphatic system disorders Leukopenia	2.0% 6/297 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	6.9% 20/290 • Number of events 32 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Blood and lymphatic system disorders Neutropenia	2.0% 6/297 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	13.8% 40/290 • Number of events 66 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Dry eye	7.1% 21/297 • Number of events 23 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	1.0% 3/290 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Eye disorders Lacrimation increased	7.7% 23/297 • Number of events 23 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	5.9% 17/290 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Constipation	19.5% 58/297 • Number of events 70 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	14.5% 42/290 • Number of events 47 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Diarrhoea	12.8% 38/297 • Number of events 54 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	22.4% 65/290 • Number of events 90 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Dry mouth	5.4% 16/297 • Number of events 20 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	3.1% 9/290 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Nausea	37.7% 112/297 • Number of events 166 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	18.6% 54/290 • Number of events 74 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Stomatitis	49.8% 148/297 • Number of events 279 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	16.2% 47/290 • Number of events 65 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Gastrointestinal disorders Vomiting	15.8% 47/297 • Number of events 65 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	9.0% 26/290 • Number of events 37 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Asthenia	23.6% 70/297 • Number of events 139 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	23.8% 69/290 • Number of events 107 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Chest pain	5.7% 17/297 • Number of events 19 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	4.1% 12/290 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Fatigue	16.2% 48/297 • Number of events 59 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	16.6% 48/290 • Number of events 70 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Malaise	7.1% 21/297 • Number of events 34 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	10.3% 30/290 • Number of events 45 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Oedema peripheral	4.4% 13/297 • Number of events 15 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	13.8% 40/290 • Number of events 56 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
General disorders Pyrexia	7.4% 22/297 • Number of events 25 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	12.1% 35/290 • Number of events 49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Infections and infestations COVID-19	11.4% 34/297 • Number of events 38 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	7.9% 23/290 • Number of events 23 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Infections and infestations Conjunctivitis	5.1% 15/297 • Number of events 19 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	1.0% 3/290 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Infections and infestations Pneumonia	6.7% 20/297 • Number of events 25 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	4.1% 12/290 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Investigations Alanine aminotransferase increased	5.4% 16/297 • Number of events 30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	3.1% 9/290 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Investigations Aspartate aminotransferase increased	5.1% 15/297 • Number of events 27 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	2.8% 8/290 • Number of events 14 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Investigations Blood creatinine increased	5.4% 16/297 • Number of events 21 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	1.4% 4/290 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Investigations Neutrophil count decreased	3.0% 9/297 • Number of events 27 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	14.1% 41/290 • Number of events 99 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Investigations Weight decreased	9.4% 28/297 • Number of events 37 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	4.5% 13/290 • Number of events 16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Investigations White blood cell count decreased	2.0% 6/297 • Number of events 15 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	9.3% 27/290 • Number of events 60 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Metabolism and nutrition disorders Decreased appetite	29.0% 86/297 • Number of events 119 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	21.7% 63/290 • Number of events 70 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Metabolism and nutrition disorders Hypoalbuminaemia	5.7% 17/297 • Number of events 25 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	4.1% 12/290 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 27/297 • Number of events 36 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	11.4% 33/290 • Number of events 46 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Musculoskeletal and connective tissue disorders Back pain	6.4% 19/297 • Number of events 23 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	5.9% 17/290 • Number of events 21 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 6/297 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	8.6% 25/290 • Number of events 33 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Nervous system disorders Dysgeusia	5.7% 17/297 • Number of events 18 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	4.8% 14/290 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Nervous system disorders Headache	9.4% 28/297 • Number of events 35 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	4.8% 14/290 • Number of events 15 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Nervous system disorders Neuropathy peripheral	1.3% 4/297 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	9.7% 28/290 • Number of events 45 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Nervous system disorders Paraesthesia	1.3% 4/297 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	6.2% 18/290 • Number of events 20 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Nervous system disorders Peripheral sensory neuropathy	1.3% 4/297 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	5.2% 15/290 • Number of events 19 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Psychiatric disorders Insomnia	5.1% 15/297 • Number of events 16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	3.4% 10/290 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Respiratory, thoracic and mediastinal disorders Cough	15.2% 45/297 • Number of events 56 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	12.8% 37/290 • Number of events 46 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.2% 51/297 • Number of events 65 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	15.9% 46/290 • Number of events 55 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.4% 10/297 • Number of events 15 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.	5.2% 15/290 • Number of events 16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months. A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.