NCT04484142 · ADVERSE EVENTS

Adverse events

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) · Source last updated 2026-03-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events (AE) were collected from the date of first treatment, up to 24 months.
Other-event reporting threshold: 5%

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.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	34 / 137	135 / 137	68 / 137

Group identifiers: EG000: Dato DXd 6.0 mg/kg Q3W

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
2
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Glaucoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Hepatic function abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
2
num At Risk
137
num Events
2
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
COVID-19 pneumonia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
21
num At Risk
137
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
15
num At Risk
137
num Events
16
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
12
num At Risk
137
num Events
12
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
7
num At Risk
137
num Events
7
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
82
num At Risk
137
num Events
117
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
79
num At Risk
137
num Events
89
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
43
num At Risk
137
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
31
num At Risk
137
num Events
41
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
17
num At Risk
137
num Events
19
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
34
num At Risk
137
num Events
40
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
21
num At Risk
137
num Events
35
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
14
num At Risk
137
num Events
17
term
Pyrexia

Complete source fields

description

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.

event Groups

deaths Num Affected
68
deaths Num At Risk
137
description
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.
id
EG000
other Num Affected
135
other Num At Risk
137
serious Num Affected
34
serious Num At Risk
137
title
Dato DXd 6.0 mg/kg Q3W

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
21
num At Risk
137
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
15
num At Risk
137
num Events
16
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
12
num At Risk
137
num Events
12
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
7
num At Risk
137
num Events
7
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
82
num At Risk
137
num Events
117
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
79
num At Risk
137
num Events
89
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
43
num At Risk
137
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
31
num At Risk
137
num Events
41
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
17
num At Risk
137
num Events
19
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
34
num At Risk
137
num Events
40
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
21
num At Risk
137
num Events
35
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
14
num At Risk
137
num Events
17
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
2
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Glaucoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Gastric perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Hepatic function abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
2
num At Risk
137
num Events
2
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA25.1
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
COVID-19 pneumonia

time Frame

Adverse events (AE) were collected from the date of first treatment, up to 24 months.

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