NCT00262847 · OUTCOME

Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)

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: LEAST_SQUARES_MEAN
Unit: units on a scale
Interval / dispersion: Standard Deviation
Time frame: At baseline, 9, 18, 36, 60, and 84 weeks

What was measured

Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.

Analysis population: Number of valid QOL assessments do not total number of patients randomized in study.

Groups in this outcome

Arm I (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 (Placebo, 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 (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 (Placebo, Paclitaxel, Carboplatin)	625
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	625
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	623

Reported measurements

prior to treatment

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	68.2	0.64	Not reported	Not reported	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	68.0	0.66	Not reported	Not reported	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	67.4	0.65	Not reported	Not reported	Not reported

prior to cycle 4

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	73.8	0.53	Not reported	Not reported	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	71.1	0.56	Not reported	Not reported	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	70.9	0.54	Not reported	Not reported	Not reported

prior to cycle 7

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	76.0	0.54	Not reported	Not reported	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	74.3	0.56	Not reported	Not reported	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	73.8	0.58	Not reported	Not reported	Not reported

prior to cycle 13

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	80.6	0.62	Not reported	Not reported	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	80.5	0.62	Not reported	Not reported	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	79.9	0.58	Not reported	Not reported	Not reported

prior to cycle 21

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	77.6	0.73	Not reported	Not reported	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	79.1	0.71	Not reported	Not reported	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	78.6	0.66	Not reported	Not reported	Not reported

6 months followup

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	75.8	0.78	Not reported	Not reported	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	77.6	0.75	Not reported	Not reported	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	77.8	0.75	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.64
value
68.2
group Id
OG001
spread
0.66
value
68.0
group Id
OG002
spread
0.65
value
67.4
title
prior to treatment
categories
measurements
group Id
OG000
spread
0.53
value
73.8
group Id
OG001
spread
0.56
value
71.1
group Id
OG002
spread
0.54
value
70.9
title
prior to cycle 4
categories
measurements
group Id
OG000
spread
0.54
value
76.0
group Id
OG001
spread
0.56
value
74.3
group Id
OG002
spread
0.58
value
73.8
title
prior to cycle 7
categories
measurements
group Id
OG000
spread
0.62
value
80.6
group Id
OG001
spread
0.62
value
80.5
group Id
OG002
spread
0.58
value
79.9
title
prior to cycle 13
categories
measurements
group Id
OG000
spread
0.73
value
77.6
group Id
OG001
spread
0.71
value
79.1
group Id
OG002
spread
0.66
value
78.6
title
prior to cycle 21
categories
measurements
group Id
OG000
spread
0.78
value
75.8
group Id
OG001
spread
0.75
value
77.6
group Id
OG002
spread
0.75
value
77.8
title
6 months followup

denoms

counts
group Id
OG000
value
625
group Id
OG001
value
625
group Id
OG002
value
623
units
Participants

description

dispersion Type

Standard Deviation

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 (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 (Placebo, 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 (Paclitaxel, Carboplatin, Bevacizumab)

param Type

LEAST_SQUARES_MEAN

population Description

Number of valid QOL assessments do not total number of patients randomized in study.

reporting Status

POSTED

time Frame

At baseline, 9, 18, 36, 60, and 84 weeks

title

Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice