NCT00390234 · ADVERSE EVENTS

Adverse events

Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma · Source last updated 2015-12-07

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Ziv-aflibercept) Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats 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	29 / 63	47 / 63	Not reported / Not reported

Group identifiers: EG000: Treatment (Ziv-aflibercept)

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
stats
group Id
EG000
num Affected
2
num At Risk
63
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
63
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
63
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
63
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
63
term
Infections and infestations - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
6
num At Risk
63
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Pruritus

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
General disorders
stats
group Id
EG000
num Affected
47
num At Risk
63
term
Fatigue

Complete source fields

event Groups

description
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats 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
47
other Num At Risk
63
serious Num Affected
29
serious Num At Risk
63
title
Treatment (Ziv-aflibercept)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
47
num At Risk
63
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
63
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
63
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
63
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
63
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Extraocular muscle paresis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
63
term
Infections and infestations - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
6
num At Risk
63
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
63
term
Pruritus

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Preserved source evidence · Not medical advice