NCT00334282 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma · Source last updated 2016-02-05

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: Date of study entry until 28 days after the last dose.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pazopanib 800 mg Pazopanib 800 mg (tablets) administered orally once a day	79 / 290	258 / 290	Not reported / Not reported
Placebo Matching Placebo administered orally once a day	28 / 145	87 / 145	Not reported / Not reported

Group identifiers: EG000: Pazopanib 800 mg · EG001: Placebo

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
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
290
group Id
EG001
num Affected
2
num At Risk
145
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Enterocutaneous fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Gastric haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Irritable bowel syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Nausea

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
149
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
75
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
59
num At Risk
290
group Id
EG001
num Affected
12
num At Risk
145
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
32
num At Risk
290
group Id
EG001
num Affected
2
num At Risk
145
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
24
num At Risk
290
group Id
EG001
num Affected
8
num At Risk
145
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
20
num At Risk
290
group Id
EG001
num Affected
9
num At Risk
145
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
109
num At Risk
290
group Id
EG001
num Affected
5
num At Risk
145
term
Hair colour changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
24
num At Risk
290
group Id
EG001
num Affected
4
num At Risk
145
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
24
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
17
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Palmar-plantar erythrodysaesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
58
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
44
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Asthenia

Complete source fields

event Groups

description
Pazopanib 800 mg (tablets) administered orally once a day
id
EG000
other Num Affected
258
other Num At Risk
290
serious Num Affected
79
serious Num At Risk
290
title
Pazopanib 800 mg
description
Matching Placebo administered orally once a day
id
EG001
other Num Affected
87
other Num At Risk
145
serious Num Affected
28
serious Num At Risk
145
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
149
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
75
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
59
num At Risk
290
group Id
EG001
num Affected
12
num At Risk
145
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
32
num At Risk
290
group Id
EG001
num Affected
2
num At Risk
145
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
24
num At Risk
290
group Id
EG001
num Affected
8
num At Risk
145
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
20
num At Risk
290
group Id
EG001
num Affected
9
num At Risk
145
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
109
num At Risk
290
group Id
EG001
num Affected
5
num At Risk
145
term
Hair colour changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
24
num At Risk
290
group Id
EG001
num Affected
4
num At Risk
145
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
24
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
17
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Palmar-plantar erythrodysaesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
58
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
44
num At Risk
290
group Id
EG001
num Affected
13
num At Risk
145
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
6
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
290
group Id
EG001
num Affected
2
num At Risk
145
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Enterocutaneous fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Gastric haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
290
group Id
EG001
num Affected
1
num At Risk
145
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Irritable bowel syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
290
group Id
EG001
num Affected
0
num At Risk
145
term
Nausea

time Frame

Date of study entry until 28 days after the last dose.

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