NCT04439110 · ADVERSE EVENTS

Adverse events

Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q) · Source last updated 2026-05-08

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: Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Trastuzumab Emtansine) Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Trastuzumab Emtansine: Given IV	12 / 38	29 / 38	30 / 38

Group identifiers: EG000: Treatment (Trastuzumab Emtansine)

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
38
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Ileal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Aspartate aminotransferase increased

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
CTCAE 4.0
stats
group Id
EG000
num Affected
9
num At Risk
38
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
38
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
14
num At Risk
38
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
38
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
38
term
Rash acneiform
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
8
num At Risk
38
term
Nausea

Complete source fields

event Groups

deaths Num Affected
30
deaths Num At Risk
38
description
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Trastuzumab Emtansine: Given IV
id
EG000
other Num Affected
29
other Num At Risk
38
serious Num Affected
12
serious Num At Risk
38
title
Treatment (Trastuzumab Emtansine)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
9
num At Risk
38
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
38
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
14
num At Risk
38
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
38
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
38
term
Rash acneiform
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
8
num At Risk
38
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
38
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
38
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Ileal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
38
term
Aspartate aminotransferase increased

time Frame

Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.

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Preserved source evidence · Not medical advice