NCT01167712 · ADVERSE EVENTS

Adverse events

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer · Source last updated 2026-05-29

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: AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Adjuvant Chemotherapy Suboptimally Debulked) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV	122 / 346	343 / 346	Not reported / Not reported
Arm II (Neoadjuvant Chemotherapy) Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery	167 / 346	340 / 346	Not reported / Not reported

Group identifiers: EG000: Arm I (Adjuvant Chemotherapy Suboptimally Debulked) · EG001: Arm II (Neoadjuvant Chemotherapy)

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Hemolytic Uremic Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
10
num At Risk
346
group Id
EG001
num Affected
8
num At Risk
346
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Cardiac Arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Left Ventricular Systolic Dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Ventricular Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Ventricular Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Paroxysmal Atrial Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Dry Eye

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
346
group Id
EG001
num Affected
2
num At Risk
346
term
Thrombotic Thrombocytopenic Purpura
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Lymph Node Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
346
group Id
EG001
num Affected
13
num At Risk
346
term
Blood And Lymphatic System Disorders - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
324
num At Risk
346
group Id
EG001
num Affected
336
num At Risk
346
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Bone Marrow Hypocellular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
346
group Id
EG001
num Affected
6
num At Risk
346
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
6
num At Risk
346
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Ventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
3
num At Risk
346
term
Supraventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
2
num At Risk
346
term
Sinus Bradycardia

Complete source fields

event Groups

description
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV
id
EG000
other Num Affected
343
other Num At Risk
346
serious Num Affected
122
serious Num At Risk
346
title
Arm I (Adjuvant Chemotherapy Suboptimally Debulked)
description
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4. Bevacizumab: Given IV Carboplatin: Given IV Computed Tomography: Correlative studies Paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
id
EG001
other Num Affected
340
other Num At Risk
346
serious Num Affected
167
serious Num At Risk
346
title
Arm II (Neoadjuvant Chemotherapy)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
346
group Id
EG001
num Affected
2
num At Risk
346
term
Thrombotic Thrombocytopenic Purpura
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Lymph Node Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
346
group Id
EG001
num Affected
13
num At Risk
346
term
Blood And Lymphatic System Disorders - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
324
num At Risk
346
group Id
EG001
num Affected
336
num At Risk
346
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Disseminated Intravascular Coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Bone Marrow Hypocellular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
346
group Id
EG001
num Affected
6
num At Risk
346
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
6
num At Risk
346
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Ventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
3
num At Risk
346
term
Supraventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
2
num At Risk
346
term
Sinus Bradycardia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Hemolytic Uremic Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
10
num At Risk
346
group Id
EG001
num Affected
8
num At Risk
346
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Cardiac Arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Left Ventricular Systolic Dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Ventricular Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Ventricular Arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
346
group Id
EG001
num Affected
1
num At Risk
346
term
Paroxysmal Atrial Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
346
group Id
EG001
num Affected
0
num At Risk
346
term
Dry Eye

time Frame

AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment.

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Preserved source evidence · Not medical advice