NCT04494425 · ADVERSE EVENTS

Adverse events

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer · Source last updated 2026-03-04

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: From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months).
Other-event reporting threshold: 5%

The Safety population included all participants who received at least 1 dose of study drug. All-cause mortality was reported in ITT population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
T-DXd Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.	88 / 434	427 / 434	161 / 436
Chemotherapy Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.	67 / 417	383 / 417	174 / 430

Group identifiers: EG000: T-DXd · EG001: Chemotherapy

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
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Anal fissure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
3
num At Risk
417
num Events
3
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
2
num At Risk
417
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
3
num At Risk
417
num Events
3
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Femoral hernia strangulated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Haematochezia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Angina pectoris

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
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
45
num At Risk
434
num Events
61
group Id
EG001
num Affected
34
num At Risk
417
num Events
36
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
35
num At Risk
434
num Events
57
group Id
EG001
num Affected
20
num At Risk
417
num Events
21
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
76
num At Risk
434
num Events
199
group Id
EG001
num Affected
63
num At Risk
417
num Events
148
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
136
num At Risk
434
num Events
179
group Id
EG001
num Affected
60
num At Risk
417
num Events
79
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
148
num At Risk
434
num Events
228
group Id
EG001
num Affected
112
num At Risk
417
num Events
177
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
24
num At Risk
434
num Events
24
group Id
EG001
num Affected
16
num At Risk
417
num Events
16
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
50
num At Risk
434
num Events
63
group Id
EG001
num Affected
20
num At Risk
417
num Events
23
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
27
num At Risk
434
num Events
33
group Id
EG001
num Affected
7
num At Risk
417
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
301
num At Risk
434
num Events
585
group Id
EG001
num Affected
126
num At Risk
417
num Events
198
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
57
num At Risk
434
num Events
75
group Id
EG001
num Affected
37
num At Risk
417
num Events
45
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
145
num At Risk
434
num Events
286
group Id
EG001
num Affected
48
num At Risk
417
num Events
63
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
98
num At Risk
434
num Events
182
group Id
EG001
num Affected
71
num At Risk
417
num Events
102
term
Asthenia

Complete source fields

description

The Safety population included all participants who received at least 1 dose of study drug. All-cause mortality was reported in ITT population.

event Groups

deaths Num Affected
161
deaths Num At Risk
436
description
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
id
EG000
other Num Affected
427
other Num At Risk
434
serious Num Affected
88
serious Num At Risk
434
title
T-DXd
deaths Num Affected
174
deaths Num At Risk
430
description
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
id
EG001
other Num Affected
383
other Num At Risk
417
serious Num Affected
67
serious Num At Risk
417
title
Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
45
num At Risk
434
num Events
61
group Id
EG001
num Affected
34
num At Risk
417
num Events
36
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
35
num At Risk
434
num Events
57
group Id
EG001
num Affected
20
num At Risk
417
num Events
21
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
76
num At Risk
434
num Events
199
group Id
EG001
num Affected
63
num At Risk
417
num Events
148
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
136
num At Risk
434
num Events
179
group Id
EG001
num Affected
60
num At Risk
417
num Events
79
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
148
num At Risk
434
num Events
228
group Id
EG001
num Affected
112
num At Risk
417
num Events
177
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
24
num At Risk
434
num Events
24
group Id
EG001
num Affected
16
num At Risk
417
num Events
16
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
50
num At Risk
434
num Events
63
group Id
EG001
num Affected
20
num At Risk
417
num Events
23
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
27
num At Risk
434
num Events
33
group Id
EG001
num Affected
7
num At Risk
417
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
301
num At Risk
434
num Events
585
group Id
EG001
num Affected
126
num At Risk
417
num Events
198
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
57
num At Risk
434
num Events
75
group Id
EG001
num Affected
37
num At Risk
417
num Events
45
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
145
num At Risk
434
num Events
286
group Id
EG001
num Affected
48
num At Risk
417
num Events
63
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
98
num At Risk
434
num Events
182
group Id
EG001
num Affected
71
num At Risk
417
num Events
102
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Anal fissure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
3
num At Risk
417
num Events
3
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
2
num At Risk
417
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
3
num At Risk
417
num Events
3
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Femoral hernia strangulated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Haematochezia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
434
num Events
1
group Id
EG001
num Affected
0
num At Risk
417
num Events
0
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
434
num Events
0
group Id
EG001
num Affected
1
num At Risk
417
num Events
1
term
Angina pectoris

time Frame

From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months).

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Preserved source evidence · Not medical advice