NCT00407485 · ADVERSE EVENTS

Adverse events

VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium · Source last updated 2014-10-20

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" include all events that were not severe adverse events regardless of grade or relation to treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Ziv-aflibercept) Patients receive 4 mg/kg VEGF Trap 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 pharmacological study: Correlative studies	4 / 22	22 / 22	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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Upper gastrointestinal hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Musculoskeletal disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Pelvic pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Pulmonary hemorrhage

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
12
num At Risk
22
num Events
34
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
7
num At Risk
22
num Events
11
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
6
num At Risk
22
num Events
13
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Enteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
3
term
Gastritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Gingival pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
4
term
Mucositis oral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
8
num At Risk
22
num Events
10
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Oral pain

Complete source fields

description

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

event Groups

description
Patients receive 4 mg/kg VEGF Trap 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 pharmacological study: Correlative studies
id
EG000
other Num Affected
22
other Num At Risk
22
serious Num Affected
4
serious Num At Risk
22
title
Treatment (Ziv-aflibercept)

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
12
num At Risk
22
num Events
34
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
3
num At Risk
22
num Events
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
7
num At Risk
22
num Events
11
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
6
num At Risk
22
num Events
13
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dry mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Enteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
3
term
Gastritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Gingival pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
4
term
Mucositis oral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
8
num At Risk
22
num Events
10
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
22
num Events
2
term
Oral pain

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Upper gastrointestinal hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Musculoskeletal disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Pelvic pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
22
num Events
1
term
Pulmonary hemorrhage

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Preserved source evidence · Not medical advice