NCT00509249 · ADVERSE EVENTS

Adverse events

Aflibercept in Treating Patients With Myelodysplastic Syndromes · Source last updated 2015-01-08

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%

"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	7 / 18	18 / 18	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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Conduction disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cardiac troponin I increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Creatinine increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Syncope
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Confusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
3
term
Hematoma

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
15
num At Risk
18
num Events
107
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Lymphatic disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
4
term
Cardiac disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cardiac pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
3
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
7
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
6
term
Flashing vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
5
num At Risk
18
num Events
7
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
5
num At Risk
18
num Events
20
term
Constipation

Complete source fields

description

"Other" Adverse Events table includes events of all grades and attributions to treatment not included in the "Serious" Adverse Event table.

event Groups

description
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
id
EG000
other Num Affected
18
other Num At Risk
18
serious Num Affected
7
serious Num At Risk
18
title
Arm I

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
15
num At Risk
18
num Events
107
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
2
term
Lymphatic disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
4
term
Cardiac disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cardiac pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
3
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
7
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
6
term
Flashing vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
5
num At Risk
18
num Events
7
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
5
num At Risk
18
num Events
20
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Conduction disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cholecystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cardiac troponin I increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Creatinine increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
2
term
Syncope
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Confusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
18
num Events
3
term
Hematoma

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Preserved source evidence · Not medical advice