NCT00434642 · ADVERSE EVENTS

Adverse events

A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma · Source last updated 2017-08-09

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: From randomization through July 19, 2013
Other-event reporting threshold: 5%

Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Carboplatin and Gemcitabine + Bevacizumab Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.	90 / 247	246 / 247	Not reported / Not reported
Carboplatin and Gemcitabine + Placebo Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.	59 / 233	233 / 233	Not reported / Not reported

Group identifiers: EG000: Carboplatin and Gemcitabine + Bevacizumab · EG001: Carboplatin and Gemcitabine + Placebo

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
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
6
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
2
num At Risk
247
group Id
EG001
num Affected
4
num At Risk
233
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Haemolytic Uraemic Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
3
num At Risk
233
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
8
num At Risk
247
group Id
EG001
num Affected
8
num At Risk
233
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Cardiac Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
2
num At Risk
233
term
Cardiac Failure Congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Cardiomyopathy

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
126
num At Risk
247
group Id
EG001
num Affected
137
num At Risk
233
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
36
num At Risk
247
group Id
EG001
num Affected
32
num At Risk
233
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
172
num At Risk
247
group Id
EG001
num Affected
158
num At Risk
233
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
135
num At Risk
247
group Id
EG001
num Affected
111
num At Risk
233
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
14
num At Risk
247
group Id
EG001
num Affected
11
num At Risk
233
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
14
num At Risk
247
group Id
EG001
num Affected
17
num At Risk
233
term
Vision Blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
247
group Id
EG001
num Affected
15
num At Risk
233
term
Abdominal Discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
24
num At Risk
247
group Id
EG001
num Affected
21
num At Risk
233
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
60
num At Risk
247
group Id
EG001
num Affected
58
num At Risk
233
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
247
group Id
EG001
num Affected
16
num At Risk
233
term
Abdominal Pain Lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
19
num At Risk
247
group Id
EG001
num Affected
17
num At Risk
233
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
132
num At Risk
247
group Id
EG001
num Affected
122
num At Risk
233
term
Constipation

Complete source fields

description

event Groups

description
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
id
EG000
other Num Affected
246
other Num At Risk
247
serious Num Affected
90
serious Num At Risk
247
title
Carboplatin and Gemcitabine + Bevacizumab
description
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
id
EG001
other Num Affected
233
other Num At Risk
233
serious Num Affected
59
serious Num At Risk
233
title
Carboplatin and Gemcitabine + Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
126
num At Risk
247
group Id
EG001
num Affected
137
num At Risk
233
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
36
num At Risk
247
group Id
EG001
num Affected
32
num At Risk
233
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
172
num At Risk
247
group Id
EG001
num Affected
158
num At Risk
233
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
135
num At Risk
247
group Id
EG001
num Affected
111
num At Risk
233
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
14
num At Risk
247
group Id
EG001
num Affected
11
num At Risk
233
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
14
num At Risk
247
group Id
EG001
num Affected
17
num At Risk
233
term
Vision Blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
247
group Id
EG001
num Affected
15
num At Risk
233
term
Abdominal Discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
24
num At Risk
247
group Id
EG001
num Affected
21
num At Risk
233
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
60
num At Risk
247
group Id
EG001
num Affected
58
num At Risk
233
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
247
group Id
EG001
num Affected
16
num At Risk
233
term
Abdominal Pain Lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
19
num At Risk
247
group Id
EG001
num Affected
17
num At Risk
233
term
Abdominal Pain Upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
132
num At Risk
247
group Id
EG001
num Affected
122
num At Risk
233
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
6
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
2
num At Risk
247
group Id
EG001
num Affected
4
num At Risk
233
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Haemolytic Uraemic Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
3
num At Risk
233
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
8
num At Risk
247
group Id
EG001
num Affected
8
num At Risk
233
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
247
group Id
EG001
num Affected
1
num At Risk
233
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Cardiac Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
2
num At Risk
233
term
Cardiac Failure Congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
247
group Id
EG001
num Affected
0
num At Risk
233
term
Cardiomyopathy

time Frame

From randomization through July 19, 2013

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice