NCT00072566 · ADVERSE EVENTS

Adverse events

Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer · Source last updated 2015-05-12

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 (Bevacizumab, Cyclophosphamide) Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO	23 / 70	70 / 70	Not reported / Not reported

Group identifiers: EG000: Treatment (Bevacizumab, Cyclophosphamide)

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
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Eye pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
3
num At Risk
70
num Events
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Cecal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
3
num At Risk
70
num Events
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Jejunal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
5
num At Risk
70
num Events
5
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Small intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
2
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Wound dehiscence

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
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
32
num At Risk
70
num Events
105
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
3
term
Lymphatic disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Myocardial ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
5
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
16
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
4
num At Risk
70
num Events
6
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
3
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
External ear inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
24
term
Hearing loss
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
18
term
Hearing test abnormal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
5
num At Risk
70
num Events
58
term
Tinnitus

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 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO
id
EG000
other Num Affected
70
other Num At Risk
70
serious Num Affected
23
serious Num At Risk
70
title
Treatment (Bevacizumab, Cyclophosphamide)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Blood disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
32
num At Risk
70
num Events
105
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
3
term
Lymphatic disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Myocardial ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
5
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
16
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
4
num At Risk
70
num Events
6
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
3
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
External ear inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
24
term
Hearing loss
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
18
term
Hearing test abnormal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
5
num At Risk
70
num Events
58
term
Tinnitus

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Eye pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
3
num At Risk
70
num Events
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Cecal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
3
num At Risk
70
num Events
3
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Jejunal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
5
num At Risk
70
num Events
5
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Small intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
2
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
70
num Events
3
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
70
num Events
1
term
Wound dehiscence

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Preserved source evidence · Not medical advice