Trial Outcomes & Findings for HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NCT NCT04619004)

NCT ID: NCT04619004

Last Updated: 2026-01-23

Results Overview

ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 277 participants
• Primary outcome timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months
• Results posted on: 2026-01-23

Participant Flow

A total of 277 participants were enrolled and randomized to treatment at clinical sites in the United States, Japan, Republic of Korea, Singapore, Taiwan, Austria, Belgium, Bulgaria, France, Germany, Italy, Netherlands, Spain, United Kingdom, and Australia. Two participants did not receive any treatment. (1 person in each treatment arm).

Participant milestones

Measure	Patritumab Deruxtecan 5.6 mg/kg Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen
Overall Study NOT COMPLETED	139	37
Overall Study STARTED	226	51
Overall Study COMPLETED	87	14

Reasons for withdrawal

Measure	Patritumab Deruxtecan 5.6 mg/kg Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received a patritumab deruxtecan up-titration regimen
Overall Study Death	114	28
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	24	7
Overall Study Other - Not specified	0	1

Baseline Characteristics

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Patritumab Deruxtecan 5.6 mg/kg n=226 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=51 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen	Total n=277 Participants Total of all reporting groups
Age, Customized <75 years	201 Participants n=270 Participants	49 Participants n=4 Participants	250 Participants n=9 Participants
Age, Continuous	62.7 years STANDARD_DEVIATION 9.86 • n=270 Participants	59.8 years STANDARD_DEVIATION 10.07 • n=4 Participants	62.2 years STANDARD_DEVIATION 9.95 • n=9 Participants
Age, Customized <65 years	122 Participants n=270 Participants	36 Participants n=4 Participants	158 Participants n=9 Participants
Age, Customized ≥65 years	104 Participants n=270 Participants	15 Participants n=4 Participants	119 Participants n=9 Participants
Age, Customized ≥75 years	25 Participants n=270 Participants	2 Participants n=4 Participants	27 Participants n=9 Participants
Sex: Female, Male Female	133 Participants n=270 Participants	29 Participants n=4 Participants	162 Participants n=9 Participants
Sex: Female, Male Male	93 Participants n=270 Participants	22 Participants n=4 Participants	115 Participants n=9 Participants
Race/Ethnicity, Customized Asian	106 Participants n=270 Participants	32 Participants n=4 Participants	138 Participants n=9 Participants
Race/Ethnicity, Customized Black or African-American	3 Participants n=270 Participants	1 Participants n=4 Participants	4 Participants n=9 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=270 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants
Race/Ethnicity, Customized White	92 Participants n=270 Participants	15 Participants n=4 Participants	107 Participants n=9 Participants
Race/Ethnicity, Customized Other	24 Participants n=270 Participants	3 Participants n=4 Participants	27 Participants n=9 Participants

PRIMARY outcome

Timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Objective response rate was assessed in the Efficacy Analysis Set.

ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=225 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=50 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)	64 Participants	8 Participants

SECONDARY outcome

Timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Duration of response rate was assessed in participants with confirmed CR or PR in the Efficacy Analysis Set.

DoR is defined as the time from the first documented confirmed response (CR or PR) to the date of progression or death due to any cause as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=64 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=8 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Duration of Response (DoR) Duration of response (BICR)	6.0 months Interval 4.4 to 7.2	7.1 months Interval 2.8 to 15.2
Duration of Response (DoR) Duration of response (Investigator)	6.9 months Interval 5.6 to 7.2	5.1 months Interval 2.6 to 9.5

SECONDARY outcome

Timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Progression-free survival was assessed in the Efficacy Analysis Set.

PFS is defined as the time from the start of study treatment to the first documentation of objective progressive disease (PD) per RECIST v1.1 or death due to any cause. PFS will be determined by BICR and by Investigator, respectively.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=225 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=50 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Progression-free Survival (PFS) Progression-free survival (BICR)	5.5 months Interval 5.1 to 5.9	6.7 months Interval 4.2 to 8.8
Progression-free Survival (PFS) Progression-free survival (Investigator)	5.5 months Interval 4.2 to 5.7	5.3 months Interval 4.0 to 8.2

SECONDARY outcome

Timeframe: Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Objective response rate was assessed in the Efficacy Analysis Set.

ORR is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR as assessed by the Investigator per RECIST v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=225 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=50 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Objective Response Rate (ORR) as Assessed by the Investigator	56 Participants	8 Participants

SECONDARY outcome

Timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Disease control rate was assessed in the Efficacy Analysis Set.

DCR is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by the Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=225 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=50 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Disease Control Rate (DCR) Disease control rate (BICR)	166 Participants	38 Participants
Disease Control Rate (DCR) Disease control rate (Investigator)	169 Participants	37 Participants

SECONDARY outcome

Timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Time to response rate was assessed in participants with confirmed CR or PR in the Efficacy Analysis Set.

TTR is defined as the time from the start of study treatment to the date of the first documentation of confirmed response (CR or PR) as assessed by BICR and Investigator per RECIST v1.1, respectively. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=64 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=8 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Time to Tumor Response (TTR) Time to response (BICR)	2.2 months Standard Deviation 1.31	1.7 months Standard Deviation 0.61
Time to Tumor Response (TTR) Time to response (Investigator)	2.5 months Standard Deviation 1.78	2.1 months Standard Deviation 1.09

SECONDARY outcome

Timeframe: Data collected from screening until time of disease progression by BICR, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 21 months

Population: Percentage change in the sum of diameters was assessed in participants with available data in the Efficacy Analysis Set.

The best percentage change in the SoD of measurable tumors is defined as the percentage change in the smallest SoD from all post-baseline tumor assessments, taking as reference the baseline SoD.

Outcome measures

Measure	Patritumab Deruxtecan 5.6 mg/kg n=210 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=49 Participants Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors Sum of diameters (BICR)	-25.66 percentage change from baseline Standard Deviation 30.39	-17.48 percentage change from baseline Standard Deviation 29.54
Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors Sum of diameters (Investigator)	-20.84 percentage change from baseline Standard Deviation 27.01	-11.46 percentage change from baseline Standard Deviation 29.25

SECONDARY outcome

Timeframe: Death date is collected until the participant discontinues the study or up to approximately 45 months

OS defined as the time from the start of study treatment to the date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline up to Day 47 post last dose

A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.

Outcome measures

Outcome data not reported

Adverse Events

Patritumab Deruxtecan 5.6 mg/kg

Serious events: 90 serious events

Other events: 223 other events

Deaths: 114 deaths

Patritumab Deruxtecan Up-Titration

Serious events: 16 serious events

Other events: 49 other events

Deaths: 28 deaths

Serious adverse events

Measure	Patritumab Deruxtecan 5.6 mg/kg n=225 participants at risk Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=50 participants at risk Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
General disorders Disease progression	4.9% 11/225 • Number of events 11 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	8.0% 4/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Pyrexia	1.3% 3/225 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Asthenia	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Fatigue	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Malaise	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Non-cardiac chest pain	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Chills	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders General physical health deterioration	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Mucosal inflammation	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Pain	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 9/225 • Number of events 9 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 4/225 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	4.0% 2/50 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 3/225 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.89% 2/225 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/225 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/225 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Pneumonia	2.2% 5/225 • Number of events 5 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations COVID-19	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Sepsis	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Septic shock	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Bacterial sepsis	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations COVID-19 pneumonia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Cellulitis	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Infectious pleural effusion	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Urinary tract infection	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Urosepsis	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Pyelonephritis	0.00% 0/225 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Nausea	2.2% 5/225 • Number of events 5 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Vomiting	1.3% 3/225 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Stomatitis	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Abdominal pain	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Colitis	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Diarrhoea	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Duodenal perforation	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Gastrointestinal perforation	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Oesophageal haemorrhage	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Pancreatic duct obstruction	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Retroperitoneal haematoma	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Constipation	0.00% 0/225 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Anaemia	2.7% 6/225 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 5/225 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Thrombocytopenia	1.8% 4/225 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Neutropenia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Seizure	1.8% 4/225 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Aphasia	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Cerebrovascular accident	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Headache	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Normal pressure hydrocephalus	0.44% 1/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Petit mal epilepsy	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Syncope	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Transient ischaemic attack	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Hypoaesthesia	0.00% 0/225 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Decreased appetite	1.8% 4/225 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Dehydration	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hyperglycaemia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hypokalaemia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hyponatraemia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	1.3% 3/225 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis to central nervous system	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Hepatobiliary disorders Jaundice cholestatic	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Hepatobiliary disorders Hepatic cytolysis	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Hepatobiliary disorders Hepatic failure	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Hepatobiliary disorders Hepatic haematoma	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Hepatobiliary disorders Hypertransaminaemia	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Injury, poisoning and procedural complications Hip fracture	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Injury, poisoning and procedural complications Ankle fracture	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Injury, poisoning and procedural complications Fall	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Injury, poisoning and procedural complications Transfusion reaction	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/225 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Cardiac disorders Cardiac tamponade	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Cardiac disorders Atrial fibrillation	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Cardiac disorders Cardiac disorder	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Back pain	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Muscular weakness	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Pathological fracture	0.44% 1/225 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Platelet count decreased	0.89% 2/225 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.

Other adverse events

Measure	Patritumab Deruxtecan 5.6 mg/kg n=225 participants at risk Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and who received patritumab deruxtecan 5.6 mg/kg IV every 3 weeks (Q3W)	Patritumab Deruxtecan Up-Titration n=50 participants at risk Participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation and received a patritumab deruxtecan up-titration regimen
Gastrointestinal disorders Nausea	65.3% 147/225 • Number of events 215 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	64.0% 32/50 • Number of events 48 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Constipation	34.2% 77/225 • Number of events 95 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	30.0% 15/50 • Number of events 19 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Diarrhoea	27.6% 62/225 • Number of events 91 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	22.0% 11/50 • Number of events 21 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Vomiting	26.7% 60/225 • Number of events 70 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	22.0% 11/50 • Number of events 15 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Stomatitis	11.6% 26/225 • Number of events 30 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	14.0% 7/50 • Number of events 7 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Abdominal pain	8.4% 19/225 • Number of events 20 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	10.0% 5/50 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Abdominal pain upper	6.2% 14/225 • Number of events 15 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Dyspepsia	6.2% 14/225 • Number of events 19 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	4.0% 2/50 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.1% 7/225 • Number of events 8 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Fatigue	30.7% 69/225 • Number of events 79 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	24.0% 12/50 • Number of events 14 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Asthenia	18.2% 41/225 • Number of events 70 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	14.0% 7/50 • Number of events 14 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Pyrexia	9.8% 22/225 • Number of events 30 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	12.0% 6/50 • Number of events 8 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Oedema peripheral	8.9% 20/225 • Number of events 22 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
General disorders Malaise	6.7% 15/225 • Number of events 23 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	12.0% 6/50 • Number of events 16 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Platelet count decreased	28.9% 65/225 • Number of events 88 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	26.0% 13/50 • Number of events 22 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Neutrophil count decreased	27.1% 61/225 • Number of events 104 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	30.0% 15/50 • Number of events 32 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations White blood cell count decreased	21.3% 48/225 • Number of events 85 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	18.0% 9/50 • Number of events 20 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Aspartate aminotransferase increased	16.9% 38/225 • Number of events 56 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	18.0% 9/50 • Number of events 13 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Alanine aminotransferase increased	11.6% 26/225 • Number of events 39 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	18.0% 9/50 • Number of events 15 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Weight decreased	10.2% 23/225 • Number of events 24 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	18.0% 9/50 • Number of events 9 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Blood alkaline phosphatase increased	9.3% 21/225 • Number of events 25 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Lymphocyte count decreased	7.1% 16/225 • Number of events 27 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Blood lactate dehydrogenase increased	5.8% 13/225 • Number of events 15 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Investigations Blood creatinine increased	5.3% 12/225 • Number of events 18 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Decreased appetite	40.9% 92/225 • Number of events 115 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	42.0% 21/50 • Number of events 28 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hypokalaemia	16.4% 37/225 • Number of events 49 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	12.0% 6/50 • Number of events 8 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hypoalbuminaemia	8.9% 20/225 • Number of events 27 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hyperglycaemia	6.7% 15/225 • Number of events 18 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	4.0% 2/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Metabolism and nutrition disorders Hyponatraemia	6.7% 15/225 • Number of events 18 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	4.0% 2/50 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Anaemia	32.9% 74/225 • Number of events 107 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	30.0% 15/50 • Number of events 23 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Thrombocytopenia	14.7% 33/225 • Number of events 59 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	10.0% 5/50 • Number of events 5 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Neutropenia	10.2% 23/225 • Number of events 35 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	10.0% 5/50 • Number of events 13 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Blood and lymphatic system disorders Leukopenia	5.3% 12/225 • Number of events 17 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Skin and subcutaneous tissue disorders Alopecia	25.3% 57/225 • Number of events 57 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Skin and subcutaneous tissue disorders Pruritus	5.8% 13/225 • Number of events 15 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	0.00% 0/50 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.8% 40/225 • Number of events 44 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	4.0% 2/50 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Cough	16.4% 37/225 • Number of events 40 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	10.0% 5/50 • Number of events 7 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.8% 22/225 • Number of events 27 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 2 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Headache	11.6% 26/225 • Number of events 28 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	18.0% 9/50 • Number of events 13 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Dysgeusia	6.2% 14/225 • Number of events 17 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	2.0% 1/50 • Number of events 1 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Nervous system disorders Dizziness	5.8% 13/225 • Number of events 16 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	8.0% 4/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Back pain	9.3% 21/225 • Number of events 25 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	14.0% 7/50 • Number of events 7 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Arthralgia	8.9% 20/225 • Number of events 22 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	8.0% 4/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Musculoskeletal and connective tissue disorders Myalgia	3.1% 7/225 • Number of events 7 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations COVID-19	8.9% 20/225 • Number of events 23 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Pneumonia	4.9% 11/225 • Number of events 12 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Infections and infestations Urinary tract infection	4.4% 10/225 • Number of events 12 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Psychiatric disorders Insomnia	7.6% 17/225 • Number of events 17 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	10.0% 5/50 • Number of events 5 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Eye disorders Vision blurred	2.7% 6/225 • Number of events 6 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	8.0% 4/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Injury, poisoning and procedural complications Fall	2.7% 6/225 • Number of events 7 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	8.0% 4/50 • Number of events 4 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.
Vascular disorders Hypertension	2.2% 5/225 • Number of events 5 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.	6.0% 3/50 • Number of events 3 • Adverse events were collected from after first dose up to 47 days post last dose, up to approximately 21 months (primary outcome data cutoff date). Safety events are reported from the Safety Analysis Set. Treatment-emergent adverse events are reported per the investigator.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo, Inc.

Phone: 9089926400

Email: CTRinfo@dsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place