NCT00833417 · ADVERSE EVENTS

Adverse events

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma · Source last updated 2026-05-11

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: For all-cause mortality, deaths were recorded from enrollment through the end of treatment-free survival follow-up (up to 5 years, 2 months). Adverse events and serious adverse events were recorded from enrollment through 45 days after the last dose of study drug or study discontinuation/termination, whichever is later (up to 4 years, 7 months).
Other-event reporting threshold: 5%

Adverse events were reported for the safety analysis population, which was defined as all enrolled patients who received any amount of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Metastatic and Locally Advanced Basal-Cell Carcinoma Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.	36 / 104	103 / 104	35 / 104

Group identifiers: EG000: Metastatic and Locally Advanced Basal-Cell Carcinoma

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
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
104
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Eye haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Aphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Cholestasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
104
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
104
term
Cellulitis

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 (Unspecified)
stats
group Id
EG000
num Affected
8
num At Risk
104
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
34
num At Risk
104
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
28
num At Risk
104
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
20
num At Risk
104
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
19
num At Risk
104
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
11
num At Risk
104
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
6
num At Risk
104
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
104
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
14
num At Risk
104
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
104
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
10
num At Risk
104
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
104
term
Sinusitis

Complete source fields

description

Adverse events were reported for the safety analysis population, which was defined as all enrolled patients who received any amount of study drug.

event Groups

deaths Num Affected
35
deaths Num At Risk
104
description
Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
id
EG000
other Num Affected
103
other Num At Risk
104
serious Num Affected
36
serious Num At Risk
104
title
Metastatic and Locally Advanced Basal-Cell Carcinoma

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
8
num At Risk
104
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
34
num At Risk
104
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
28
num At Risk
104
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
20
num At Risk
104
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
19
num At Risk
104
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
11
num At Risk
104
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
6
num At Risk
104
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
104
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
14
num At Risk
104
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
104
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
10
num At Risk
104
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
104
term
Sinusitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
104
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Eye haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Aphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
104
term
Cholestasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
104
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
104
term
Cellulitis

time Frame

For all-cause mortality, deaths were recorded from enrollment through the end of treatment-free survival follow-up (up to 5 years, 2 months). Adverse events and serious adverse events were recorded from enrollment through 45 days after the last dose of study drug or study discontinuation/termination, whichever is later (up to 4 years, 7 months).

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Preserved source evidence · Not medical advice