NCT00459862 · ADVERSE EVENTS

Adverse events

Pazopanib in Treating Patients With Malignant Pleural Mesothelioma · Source last updated 2015-02-24

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.	13 / 34	34 / 34	Not reported / Not reported

Group identifiers: EG000: Arm I

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 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Alanine aminotransferase increased

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 9
stats
group Id
EG000
num Affected
17
num At Risk
34
num Events
69
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
6
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
4
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
7
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
16
num At Risk
34
num Events
42
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Anal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
6
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
15
num At Risk
34
num Events
55
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
2
term
Dry mouth

Complete source fields

event Groups

description
Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
34
other Num At Risk
34
serious Num Affected
13
serious Num At Risk
34
title
Arm I

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
17
num At Risk
34
num Events
69
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
2
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
6
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
4
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
7
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
16
num At Risk
34
num Events
42
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Anal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
6
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
15
num At Risk
34
num Events
55
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
2
term
Dry mouth

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Alanine aminotransferase increased

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Preserved source evidence · Not medical advice