NCT00262847 · OUTCOME

Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2019-07-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 5 years

What was measured

Eligible and Evaluable patients

Analysis population: Eligible and evaluable patients

Groups in this outcome

Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)

Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)

Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	621
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	624
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	619

Reported measurements

White blood cell

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	317	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	328	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	327	Not reported	Not reported	Not reported	Not reported

Absolute neutrophil count

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	540	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	543	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	536	Not reported	Not reported	Not reported	Not reported

Hemoglobin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	91	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	86	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	74	Not reported	Not reported	Not reported	Not reported

Platelets

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	93	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	122	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	131	Not reported	Not reported	Not reported	Not reported

Other hematologic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	13	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	13	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	9	Not reported	Not reported	Not reported	Not reported

Allergy/Immunology

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	23	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	25	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	14	Not reported	Not reported	Not reported	Not reported

Auditory/Ear

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	1	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	2	Not reported	Not reported	Not reported	Not reported

hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	10	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	36	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	65	Not reported	Not reported	Not reported	Not reported

Cardiac

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	14	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	12	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	18	Not reported	Not reported	Not reported	Not reported

Coagulation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	5	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	7	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	8	Not reported	Not reported	Not reported	Not reported

Constitutional

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	62	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	61	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	83	Not reported	Not reported	Not reported	Not reported

Dermatologic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	13	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	20	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	16	Not reported	Not reported	Not reported	Not reported

Endocrine

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	4	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	4	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	2	Not reported	Not reported	Not reported	Not reported

Gastrointestinal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	96	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	112	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	122	Not reported	Not reported	Not reported	Not reported

Genitourinary/Renal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	13	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	8	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	8	Not reported	Not reported	Not reported	Not reported

Hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	5	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	9	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	15	Not reported	Not reported	Not reported	Not reported

Hepatobiliary

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	2	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	3	Not reported	Not reported	Not reported	Not reported

Infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	75	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	73	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	95	Not reported	Not reported	Not reported	Not reported

Lymphatics

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	4	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	3	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	3	Not reported	Not reported	Not reported	Not reported

Metabolic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	91	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	87	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	101	Not reported	Not reported	Not reported	Not reported

Musculoskeletal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	16	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	17	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	21	Not reported	Not reported	Not reported	Not reported

Neurosensory

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	23	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	26	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	28	Not reported	Not reported	Not reported	Not reported

Other neurological

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	44	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	42	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	65	Not reported	Not reported	Not reported	Not reported

Ocular/Visual

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	4	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	4	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	74	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	82	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	101	Not reported	Not reported	Not reported	Not reported

Pulmonary

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	29	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	36	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	32	Not reported	Not reported	Not reported	Not reported

Vascular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	37	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	33	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	40	Not reported	Not reported	Not reported	Not reported

Death, not CTC coded

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	5	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	8	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	10	Not reported	Not reported	Not reported	Not reported

Sexual/Reproductive

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)	1	Not reported	Not reported	Not reported	Not reported
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
317
group Id
OG001
value
328
group Id
OG002
value
327
title
White blood cell
categories
measurements
group Id
OG000
value
540
group Id
OG001
value
543
group Id
OG002
value
536
title
Absolute neutrophil count
categories
measurements
group Id
OG000
value
91
group Id
OG001
value
86
group Id
OG002
value
74
title
Hemoglobin
categories
measurements
group Id
OG000
value
93
group Id
OG001
value
122
group Id
OG002
value
131
title
Platelets
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
13
group Id
OG002
value
9
title
Other hematologic
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
25
group Id
OG002
value
14
title
Allergy/Immunology
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
title
Auditory/Ear
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
36
group Id
OG002
value
65
title
hypertension
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
12
group Id
OG002
value
18
title
Cardiac
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
8
title
Coagulation
categories
measurements
group Id
OG000
value
62
group Id
OG001
value
61
group Id
OG002
value
83
title
Constitutional
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
20
group Id
OG002
value
16
title
Dermatologic

denoms

counts
group Id
OG000
value
621
group Id
OG001
value
624
group Id
OG002
value
619
units
Participants

description

Eligible and Evaluable patients

groups

description
Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
id
OG000
title
Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)
description
Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
id
OG001
title
Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)
description
Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
id
OG002
title
Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)

param Type

COUNT_OF_PARTICIPANTS

population Description

Eligible and evaluable patients

reporting Status

POSTED

time Frame

Up to 5 years

title

Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice