NCT00509041 · ADVERSE EVENTS

Adverse events

Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma · Source last updated 2016-08-11

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dasatinib Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma	15 / 43	35 / 43	Not reported / Not reported

Group identifiers: EG000: Dasatinib

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 6
stats
group Id
EG000
num Affected
8
num At Risk
43
num Events
11
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
5
num At Risk
43
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Hemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
8
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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
24
num At Risk
43
num Events
64
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
19
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
3
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Gastrointestinal disorder

Complete source fields

event Groups

description
Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
id
EG000
other Num Affected
35
other Num At Risk
43
serious Num Affected
15
serious Num At Risk
43
title
Dasatinib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
24
num At Risk
43
num Events
64
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
43
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
14
num At Risk
43
num Events
19
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
43
num Events
3
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Gastrointestinal disorder

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
8
num At Risk
43
num Events
11
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
43
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
5
num At Risk
43
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
7
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
43
num Events
1
term
Hemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
43
num Events
8
term
Nausea

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Preserved source evidence · Not medical advice