Trial Outcomes & Findings for Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) (NCT NCT04484142)

Last Updated: 2025-11-10

Results Overview

ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

Results posted on

2025-11-10

Participant Flow

A total of 137 participants who met all inclusion criteria and no exclusion criteria were enrolled to receive Dato-DXd treatment in 50 clinical sites, North America= 15, Europe= 14, Asia Pacific= 21.

Participant milestones

Participant milestones
Measure	Dato DXd 6.0 mg/kg Q3W Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Overall Study STARTED	137
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	117

Reasons for withdrawal

Reasons for withdrawal
Measure	Dato DXd 6.0 mg/kg Q3W Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Overall Study Adverse Event	13
Overall Study Progressive Disease	87
Overall Study Clinical Progression	10
Overall Study Withdrawal by Subject	6
Overall Study Physician Decision	1

Baseline Characteristics

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dato DXd 6.0 mg/kg Q3W n=137 Participants Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants
Age, Continuous	59.5 years STANDARD_DEVIATION 11.15 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	78 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

Population: Outcome Measure was assessed in the Full Analysis Set, which includes all subjects who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Dato DXd 6.0 mg/kg Q3W n=137 Participants Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)	35.8 percentage of participants Interval 27.8 to 44.4

Serious events: 34 serious events

Other events: 135 other events

Deaths: 68 deaths

Serious adverse events

Serious adverse events
Measure	Dato DXd 6.0 mg/kg Q3W n=137 participants at risk Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Eye disorders Cataract	0.73% 1/137 • Number of events 2 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Eye disorders Glaucoma	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Dysphagia	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Gastric perforation	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Stomatitis	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Vomiting	0.73% 1/137 • Number of events 2 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
General disorders Fatigue	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Immune system disorders Hypersensitivity	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Infections and infestations COVID-19	1.5% 2/137 • Number of events 2 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Infections and infestations COVID-19 pneumonia	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Infections and infestations Herpes zoster	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Infections and infestations Influenza	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Infections and infestations Septic shock	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Ejection fraction decreased	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Oxygen saturation decreased	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Aphasia	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Cerebral infarction	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Dizziness	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Headache	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Spinal cord compression	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Psychiatric disorders Confusional state	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Psychiatric disorders Mental status changes	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.9% 4/137 • Number of events 4 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 3/137 • Number of events 4 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Vascular disorders Deep vein thrombosis	0.73% 1/137 • Number of events 1 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.

Other adverse events

Other adverse events
Measure	Dato DXd 6.0 mg/kg Q3W n=137 participants at risk Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
General disorders Asthenia	15.3% 21/137 • Number of events 35 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
General disorders Pyrexia	10.2% 14/137 • Number of events 17 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
General disorders Malaise	8.0% 11/137 • Number of events 13 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
General disorders Oedema peripheral	5.1% 7/137 • Number of events 7 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Blood and lymphatic system disorders Anaemia	15.3% 21/137 • Number of events 24 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Eye disorders Dry eye	10.9% 15/137 • Number of events 16 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Eye disorders Vision blurred	8.8% 12/137 • Number of events 12 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Eye disorders Keratitis	5.1% 7/137 • Number of events 7 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Nausea	59.9% 82/137 • Number of events 117 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Stomatitis	57.7% 79/137 • Number of events 89 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Constipation	31.4% 43/137 • Number of events 47 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Vomiting	22.6% 31/137 • Number of events 41 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Gastrointestinal disorders Diarrhoea	12.4% 17/137 • Number of events 19 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
General disorders Fatigue	24.8% 34/137 • Number of events 40 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Infections and infestations COVID-19	14.6% 20/137 • Number of events 20 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	6.6% 9/137 • Number of events 9 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Weight decreased	10.2% 14/137 • Number of events 14 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Amylase increased	8.8% 12/137 • Number of events 17 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Aspartate aminotransferase increased	6.6% 9/137 • Number of events 9 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Blood creatinine increased	6.6% 9/137 • Number of events 12 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations White blood cell count decreased	6.6% 9/137 • Number of events 13 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Alanine aminotransferase increased	5.8% 8/137 • Number of events 10 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Investigations Neutrophil count decreased	5.8% 8/137 • Number of events 10 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Blood and lymphatic system disorders Blood alkaline phosphatase increased	5.1% 7/137 • Number of events 8 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	27.0% 37/137 • Number of events 44 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	6.6% 9/137 • Number of events 10 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	5.8% 8/137 • Number of events 9 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	5.8% 8/137 • Number of events 11 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.8% 8/137 • Number of events 8 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.1% 7/137 • Number of events 7 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Headache	10.2% 14/137 • Number of events 14 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Dizziness	6.6% 9/137 • Number of events 9 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Nervous system disorders Dysgeusia	5.8% 8/137 • Number of events 8 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.6% 20/137 • Number of events 21 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.9% 15/137 • Number of events 16 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.8% 8/137 • Number of events 8 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	51.1% 70/137 • Number of events 71 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Skin and subcutaneous tissue disorders Rash	15.3% 21/137 • Number of events 27 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	10.2% 14/137 • Number of events 14 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.3% 10/137 • Number of events 11 • Adverse events (AE) were collected from the date of first treatment, up to 24 months. A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.

Additional Information

Contact for Clinical Trial Information

Daiichi Sanyko, Inc

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place