NCT01524978 · ADVERSE EVENTS

Adverse events

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers · Source last updated 2017-11-20

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 baseline up to approximately 3 years
Other-event reporting threshold: 5%

The safety population included all participants who received at least one dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.	11 / 27	26 / 27	Not reported / Not reported
Pooled Arm - Vemurafenib Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.	91 / 181	177 / 181	Not reported / Not reported

Group identifiers: EG000: Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab · EG001: Pooled Arm - Vemurafenib

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
27
group Id
EG001
num Affected
25
num At Risk
181
term
Squamous cell carcinoma of skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
18
num At Risk
181
term
Keratoacanthoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
7
num At Risk
181
term
Basal cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
1
num At Risk
181
term
Squamous cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
1
num At Risk
181
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
2
num At Risk
181
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Cholestasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Gamma-glutamyltransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
4
num At Risk
181
term
Acute kidney injury

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 19.1
stats
group Id
EG000
num Affected
3
num At Risk
27
group Id
EG001
num Affected
30
num At Risk
181
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
12
num At Risk
27
group Id
EG001
num Affected
12
num At Risk
181
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
4
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
5
num At Risk
27
group Id
EG001
num Affected
26
num At Risk
181
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
13
num At Risk
27
group Id
EG001
num Affected
49
num At Risk
181
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
9
num At Risk
27
group Id
EG001
num Affected
54
num At Risk
181
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
4
num At Risk
27
group Id
EG001
num Affected
19
num At Risk
181
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
8
num At Risk
27
group Id
EG001
num Affected
41
num At Risk
181
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
10
num At Risk
27
group Id
EG001
num Affected
39
num At Risk
181
term
Asthenia

Complete source fields

description

The safety population included all participants who received at least one dose of study medication.

event Groups

description
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
id
EG000
other Num Affected
26
other Num At Risk
27
serious Num Affected
11
serious Num At Risk
27
title
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
description
Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.
id
EG001
other Num Affected
177
other Num At Risk
181
serious Num Affected
91
serious Num At Risk
181
title
Pooled Arm - Vemurafenib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
27
group Id
EG001
num Affected
30
num At Risk
181
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
12
num At Risk
27
group Id
EG001
num Affected
12
num At Risk
181
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
4
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
5
num At Risk
27
group Id
EG001
num Affected
26
num At Risk
181
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
13
num At Risk
27
group Id
EG001
num Affected
49
num At Risk
181
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
9
num At Risk
27
group Id
EG001
num Affected
54
num At Risk
181
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
4
num At Risk
27
group Id
EG001
num Affected
19
num At Risk
181
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
8
num At Risk
27
group Id
EG001
num Affected
41
num At Risk
181
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
10
num At Risk
27
group Id
EG001
num Affected
39
num At Risk
181
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
27
group Id
EG001
num Affected
25
num At Risk
181
term
Squamous cell carcinoma of skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
27
group Id
EG001
num Affected
18
num At Risk
181
term
Keratoacanthoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
7
num At Risk
181
term
Basal cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
1
num At Risk
181
term
Squamous cell carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
1
num At Risk
181
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
2
num At Risk
181
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Cholestasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
0
num At Risk
181
term
Gamma-glutamyltransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
27
group Id
EG001
num Affected
4
num At Risk
181
term
Acute kidney injury

time Frame

From baseline up to approximately 3 years

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Preserved source evidence · Not medical advice