NCT00072475 · ADVERSE EVENTS

Adverse events

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes · Source last updated 2016-08-01

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
Vatalanib After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)	51 / 153	134 / 153	Not reported / Not reported

Group identifiers: EG000: Vatalanib

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 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
153
num Events
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
43
num At Risk
153
num Events
48
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
153
num Events
2
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
153
num Events
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Ascites

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 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
2
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
12
num At Risk
153
num Events
12
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
121
num At Risk
153
num Events
324
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Spleen disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Transfusion: pRBCs for pediatric BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
153
num Events
2
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
153
num Events
4
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
153
num Events
2
term
Myocardial ischemia

Complete source fields

event Groups

description
After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
id
EG000
other Num Affected
134
other Num At Risk
153
serious Num Affected
51
serious Num At Risk
153
title
Vatalanib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
2
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
12
num At Risk
153
num Events
12
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
121
num At Risk
153
num Events
324
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Spleen disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Transfusion: pRBCs for pediatric BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
153
num Events
2
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
153
num Events
4
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
153
num Events
2
term
Myocardial ischemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
153
num Events
8
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
43
num At Risk
153
num Events
48
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
153
num Events
2
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
153
num Events
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
153
num Events
1
term
Ascites

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