NCT00803062 · OUTCOME

To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.

Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical 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: From date of enrollment until 30 days after treatment completion

What was measured

The number of patients on each arm who have Grade 3 AE or higher toxicity.

Analysis population: Eligible and treated patients

Groups in this outcome

Arm I (Paclitaxel and Cisplatin)

Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity

Arm II (Paclitaxel, Cisplatin, Bevacizumab)

Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity

Arm III (Topotecan Hydrochloride and Paclitaxel)

Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity

Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)

Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity

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 (Paclitaxel and Cisplatin)	114
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	115
Arm III (Topotecan Hydrochloride and Paclitaxel)	111
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	112

Reported measurements

Leukopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	34	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	48	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	48	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	66	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	6	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	5	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	5	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	9	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	48	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	61	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	61	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	79	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	33	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	29	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	23	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	30	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 (Paclitaxel and Cisplatin)	3	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	8	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	6	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	6	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 (Paclitaxel and Cisplatin)	4	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	4	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	1	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	2	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 (Paclitaxel and Cisplatin)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	0	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported

Cardiac

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	2	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	16	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	4	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	14	Not reported	Not reported	Not reported	Not reported

Coagulation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	4	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	4	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	1	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported

Constitutional

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	12	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	16	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	13	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	16	Not reported	Not reported	Not reported	Not reported

Dermatologic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	0	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	4	Not reported	Not reported	Not reported	Not reported

Endocrine

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	2	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	1	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported

Gastrointestinal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	22	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	29	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	11	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	22	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 (Paclitaxel and Cisplatin)	10	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	8	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	7	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	14	Not reported	Not reported	Not reported	Not reported

Hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	4	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	7	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	5	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	9	Not reported	Not reported	Not reported	Not reported

Hepatobiliary

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	0	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	0	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported

Infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	17	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	18	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	19	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	30	Not reported	Not reported	Not reported	Not reported

Lymphatics

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	3	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	1	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	1	Not reported	Not reported	Not reported	Not reported

Metabolic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	18	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	23	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	11	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	17	Not reported	Not reported	Not reported	Not reported

Musculoskeletal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	2	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	2	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	2	Not reported	Not reported	Not reported	Not reported

Neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	9	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	12	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	2	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	3	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 (Paclitaxel and Cisplatin)	8	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	5	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	7	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	9	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	21	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	30	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	22	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	27	Not reported	Not reported	Not reported	Not reported

Pulmonary

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	3	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	9	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	5	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	4	Not reported	Not reported	Not reported	Not reported

Vascular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Paclitaxel and Cisplatin)	8	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	17	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	6	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	7	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 (Paclitaxel and Cisplatin)	1	Not reported	Not reported	Not reported	Not reported
Arm II (Paclitaxel, Cisplatin, Bevacizumab)	2	Not reported	Not reported	Not reported	Not reported
Arm III (Topotecan Hydrochloride and Paclitaxel)	2	Not reported	Not reported	Not reported	Not reported
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
34
group Id
OG001
value
48
group Id
OG002
value
48
group Id
OG003
value
66
title
Leukopenia
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
9
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
48
group Id
OG001
value
61
group Id
OG002
value
61
group Id
OG003
value
79
title
Neutropenia
categories
measurements
group Id
OG000
value
33
group Id
OG001
value
29
group Id
OG002
value
23
group Id
OG003
value
30
title
Anemia
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
8
group Id
OG002
value
6
group Id
OG003
value
6
title
Other hematologic
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
1
group Id
OG003
value
2
title
Allergy/Immunology
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Auditory/Ear
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
16
group Id
OG002
value
4
group Id
OG003
value
14
title
Cardiac
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
1
group Id
OG003
value
0
title
Coagulation
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
16
group Id
OG002
value
13
group Id
OG003
value
16
title
Constitutional
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
4
title
Dermatologic
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
title
Endocrine

denoms

counts
group Id
OG000
value
114
group Id
OG001
value
115
group Id
OG002
value
111
group Id
OG003
value
112
units
Participants

description

The number of patients on each arm who have Grade 3 AE or higher toxicity.

groups

description
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
id
OG000
title
Arm I (Paclitaxel and Cisplatin)
description
Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
id
OG001
title
Arm II (Paclitaxel, Cisplatin, Bevacizumab)
description
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
id
OG002
title
Arm III (Topotecan Hydrochloride and Paclitaxel)
description
Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
id
OG003
title
Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)

param Type

COUNT_OF_PARTICIPANTS

population Description

Eligible and treated patients

reporting Status

POSTED

time Frame

From date of enrollment until 30 days after treatment completion

title

To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice