NCT04439292 · ADVERSE EVENTS

Adverse events

Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) · Source last updated 2026-06-12

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

All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Dabrafenib, Trametinib) Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	23 / 43	43 / 43	24 / 44

Group identifiers: EG000: Treatment (Dabrafenib, Trametinib)

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
1
num At Risk
43
num Events
23
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
23
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Rash maculo-papular
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
43
num Events
23
term
Skin and subcutaneous tissue disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
23
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
43
num Events
23
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Small intestine ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Lung 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
43
num Events
23
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
43
num Events
23
term
Wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Alanine 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
11
num At Risk
43
num Events
43
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
43
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
21
num At Risk
43
num Events
43
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
43
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
30
num At Risk
43
num Events
43
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
20
num At Risk
43
num Events
43
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
43
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
43
term
Malaise
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
43
num Events
43
term
Hyperhidrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
43
num Events
43
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
43
num Events
43
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
12
num At Risk
43
num Events
43
term
Rash maculo-papular

Complete source fields

description

All patients enrolled were included in the all-cause mortality analysis. Forty-three patients were included in the toxicity analysis (excluding one who did not receive treatment).

event Groups

deaths Num Affected
24
deaths Num At Risk
44
description
Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
43
other Num At Risk
43
serious Num Affected
23
serious Num At Risk
43
title
Treatment (Dabrafenib, Trametinib)

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
11
num At Risk
43
num Events
43
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
43
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
21
num At Risk
43
num Events
43
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
43
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
30
num At Risk
43
num Events
43
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
20
num At Risk
43
num Events
43
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
43
term
Flu like symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
43
term
Malaise
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
43
num Events
43
term
Hyperhidrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
43
num Events
43
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
43
num Events
43
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
12
num At Risk
43
num Events
43
term
Rash maculo-papular

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
23
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Rash maculo-papular
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
43
num Events
23
term
Skin and subcutaneous tissue disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
23
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
43
num Events
23
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Small intestine ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Lung 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
43
num Events
23
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
43
num Events
23
term
Wound infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
23
term
Alanine aminotransferase increased

time Frame

Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice