NCT00387764 · ADVERSE EVENTS

Adverse events

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer · Source last updated 2014-01-14

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: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pazopanib 800 mg Participants received pazopanib 800 milligrams (mg) once daily.	27 / 80	72 / 80	Not reported / Not reported

Group identifiers: EG000: Pazopanib 800 mg

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
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Sudden death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Bone abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Infection

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
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
35
num At Risk
80
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
20
num At Risk
80
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
15
num At Risk
80
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
15
num At Risk
80
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
80
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
80
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
80
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
35
num At Risk
80
term
Hair colour changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
12
num At Risk
80
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
80
term
Palmar-plantar erythrodysaesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
80
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
35
num At Risk
80
term
Hypertension

Complete source fields

event Groups

description
Participants received pazopanib 800 milligrams (mg) once daily.
id
EG000
other Num Affected
72
other Num At Risk
80
serious Num Affected
27
serious Num At Risk
80
title
Pazopanib 800 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
35
num At Risk
80
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
20
num At Risk
80
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
15
num At Risk
80
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
15
num At Risk
80
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
80
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
80
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
80
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
35
num At Risk
80
term
Hair colour changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
12
num At Risk
80
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
80
term
Palmar-plantar erythrodysaesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
80
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
35
num At Risk
80
term
Hypertension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
80
term
Sudden death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Bone abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
80
term
Infection

time Frame

Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 6.230 years).

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Preserved source evidence · Not medical advice