NCT01682083 · ADVERSE EVENTS

Adverse events

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). · Source last updated 2026-04-21

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 (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.
Other-event reporting threshold: 5%

Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dabrafenib + Trametinib Combination Therapy Dabrafenib + Trametinib combination therapy: Events up to 30 days post-treatment	155 / 435	414 / 435	4 / 438
Dabrafenib and Trametinib Placebos Dabrafenib and trametinib placebos: Events up to 30 days post-treatment	44 / 432	343 / 432	1 / 432
Dabrafenib + Trametinib Combination Therapy (Post-treatment) Dabrafenib + Trametinib combination therapy (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events	0 / 0	0 / 0	121 / 431
Dabrafenib and Trametinib Placebos (Post-treatment) Dabrafenib and trametinib placebos (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events	0 / 0	0 / 0	135 / 431

Group identifiers: EG000: Dabrafenib + Trametinib Combination Therapy · EG001: Dabrafenib and Trametinib Placebos · EG002: Dabrafenib + Trametinib Combination Therapy (Post-treatment) · EG003: Dabrafenib and Trametinib Placebos (Post-treatment)

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
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
435
group Id
EG001
num Affected
1
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Cardiac ventricular thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
435
group Id
EG001
num Affected
1
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
435
group Id
EG001
num Affected
1
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Ovarian dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
4
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Central serous chorioretinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Chorioretinopathy

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
MedDRA (26.0)
stats
group Id
EG000
num Affected
34
num At Risk
435
group Id
EG001
num Affected
4
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
22
num At Risk
435
group Id
EG001
num Affected
13
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
27
num At Risk
435
group Id
EG001
num Affected
16
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
33
num At Risk
435
group Id
EG001
num Affected
23
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
31
num At Risk
435
group Id
EG001
num Affected
27
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
51
num At Risk
435
group Id
EG001
num Affected
27
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
143
num At Risk
435
group Id
EG001
num Affected
65
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
41
num At Risk
435
group Id
EG001
num Affected
15
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
23
num At Risk
435
group Id
EG001
num Affected
26
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
173
num At Risk
435
group Id
EG001
num Affected
88
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
120
num At Risk
435
group Id
EG001
num Affected
43
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
58
num At Risk
435
group Id
EG001
num Affected
42
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Asthenia

Complete source fields

description

event Groups

deaths Num Affected
4
deaths Num At Risk
438
description
Dabrafenib + Trametinib combination therapy: Events up to 30 days post-treatment
id
EG000
other Num Affected
414
other Num At Risk
435
serious Num Affected
155
serious Num At Risk
435
title
Dabrafenib + Trametinib Combination Therapy
deaths Num Affected
1
deaths Num At Risk
432
description
Dabrafenib and trametinib placebos: Events up to 30 days post-treatment
id
EG001
other Num Affected
343
other Num At Risk
432
serious Num Affected
44
serious Num At Risk
432
title
Dabrafenib and Trametinib Placebos
deaths Num Affected
121
deaths Num At Risk
431
description
Dabrafenib + Trametinib combination therapy (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dabrafenib + Trametinib Combination Therapy (Post-treatment)
deaths Num Affected
135
deaths Num At Risk
431
description
Dabrafenib and trametinib placebos (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dabrafenib and Trametinib Placebos (Post-treatment)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
34
num At Risk
435
group Id
EG001
num Affected
4
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
22
num At Risk
435
group Id
EG001
num Affected
13
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
27
num At Risk
435
group Id
EG001
num Affected
16
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
33
num At Risk
435
group Id
EG001
num Affected
23
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
31
num At Risk
435
group Id
EG001
num Affected
27
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
51
num At Risk
435
group Id
EG001
num Affected
27
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
143
num At Risk
435
group Id
EG001
num Affected
65
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
41
num At Risk
435
group Id
EG001
num Affected
15
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
23
num At Risk
435
group Id
EG001
num Affected
26
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
173
num At Risk
435
group Id
EG001
num Affected
88
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
120
num At Risk
435
group Id
EG001
num Affected
43
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
58
num At Risk
435
group Id
EG001
num Affected
42
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
2
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
435
group Id
EG001
num Affected
1
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Cardiac ventricular thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
435
group Id
EG001
num Affected
1
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
435
group Id
EG001
num Affected
1
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Inappropriate antidiuretic hormone secretion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Ovarian dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
4
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Central serous chorioretinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
435
group Id
EG001
num Affected
0
num At Risk
432
group Id
EG002
num At Risk
0
group Id
EG003
num At Risk
0
term
Chorioretinopathy

time Frame

Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 12 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 126 months.

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