NCT00565851 · OUTCOME

Patient Reported Quality of Life (Chemotherapy Analysis)

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2025-12-30

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

Measure: LEAST_SQUARES_MEAN
Unit: score on a scale
Interval / dispersion: Standard Error
Time frame: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.

What was measured

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.

Analysis population: Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).

Groups in this outcome

Paclitaxel and Carboplatin Chemotherapy

All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis

Paclitaxel and Carboplatin Chemotherapy With Bevacizumab

All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis

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
Paclitaxel and Carboplatin Chemotherapy	298
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab	302

Reported measurements

Prior to cycle 1 (baseline)

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Paclitaxel and Carboplatin Chemotherapy	75.8	0.8	Not reported	Not reported	Not reported
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab	75.3	0.9	Not reported	Not reported	Not reported

Prior to cycle 3

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Paclitaxel and Carboplatin Chemotherapy	74.2	1.0	Not reported	Not reported	Not reported
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab	73.4	0.9	Not reported	Not reported	Not reported

Prior to cycle 6

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Paclitaxel and Carboplatin Chemotherapy	73.3	1.0	Not reported	Not reported	Not reported
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab	72.3	1.0	Not reported	Not reported	Not reported

6 months post cycle 1

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Paclitaxel and Carboplatin Chemotherapy	77.1	1.0	Not reported	Not reported	Not reported
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab	77.2	1.0	Not reported	Not reported	Not reported

12 months post cycle 1

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Paclitaxel and Carboplatin Chemotherapy	77.0	1.1	Not reported	Not reported	Not reported
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab	77.8	1.0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.8
value
75.8
group Id
OG001
spread
0.9
value
75.3
title
Prior to cycle 1 (baseline)
categories
measurements
group Id
OG000
spread
1.0
value
74.2
group Id
OG001
spread
0.9
value
73.4
title
Prior to cycle 3
categories
measurements
group Id
OG000
spread
1.0
value
73.3
group Id
OG001
spread
1.0
value
72.3
title
Prior to cycle 6
categories
measurements
group Id
OG000
spread
1.0
value
77.1
group Id
OG001
spread
1.0
value
77.2
title
6 months post cycle 1
categories
measurements
group Id
OG000
spread
1.1
value
77.0
group Id
OG001
spread
1.0
value
77.8
title
12 months post cycle 1

denoms

counts
group Id
OG000
value
298
group Id
OG001
value
302
units
Participants

description

dispersion Type

Standard Error

groups

description
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
id
OG000
title
Paclitaxel and Carboplatin Chemotherapy
description
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
id
OG001
title
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab

param Type

LEAST_SQUARES_MEAN

population Description

Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).

reporting Status

POSTED

time Frame

1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.

title

Patient Reported Quality of Life (Chemotherapy Analysis)

type

SECONDARY

unit Of Measure

score on a scale

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Preserved source evidence · Not medical advice