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NCT01059630 · OUTCOME

CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) · Source last updated 2020-01-13

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

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

What was measured

The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Analysis population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

Groups in this outcome

Bendamustine Alone

Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.

Obinutuzumab + Bendamustine

Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).

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
Bendamustine Alone	185
Obinutuzumab + Bendamustine	186

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	185
Obinutuzumab + Bendamustine	186

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	79.86	16.25	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	80.78	16.27	Not reported	Not reported	Not reported

CFB at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	154
Obinutuzumab + Bendamustine	154

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-1.87	12.28	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.11	10.30	Not reported	Not reported	Not reported

CFB at Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	5
Obinutuzumab + Bendamustine	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-9.37	9.89	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.52	4.98	Not reported	Not reported	Not reported

CFB at Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	140
Obinutuzumab + Bendamustine	145

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-2.44	12.01	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.06	11.13	Not reported	Not reported	Not reported

CFB at End of Induction Treatment

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	146
Obinutuzumab + Bendamustine	140

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-1.84	13.83	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	-0.92	11.77	Not reported	Not reported	Not reported

CFB at Follow-up Month 2

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	107
Obinutuzumab + Bendamustine	133

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.53	13.42	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.22	12.01	Not reported	Not reported	Not reported

CFB at Follow-up Month 4

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	95
Obinutuzumab + Bendamustine	120

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.55	11.47	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.06	13.00	Not reported	Not reported	Not reported

CFB at Follow-up Month 6

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	75
Obinutuzumab + Bendamustine	111

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.54	10.68	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.24	11.40	Not reported	Not reported	Not reported

CFB at Follow-up Month 8

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	74
Obinutuzumab + Bendamustine	104

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-0.53	10.15	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.49	11.45	Not reported	Not reported	Not reported

CFB at Follow-up Month 10

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	57
Obinutuzumab + Bendamustine	88

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.29	11.39	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.46	11.83	Not reported	Not reported	Not reported

CFB at Follow-up Month 12

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	53
Obinutuzumab + Bendamustine	90

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.68	13.16	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.82	14.29	Not reported	Not reported	Not reported

CFB at Follow-up Month 14

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	45
Obinutuzumab + Bendamustine	84

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.48	9.42	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.94	11.97	Not reported	Not reported	Not reported

CFB at Follow-up Month 16

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	42
Obinutuzumab + Bendamustine	82

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.54	10.61	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	4.09	12.87	Not reported	Not reported	Not reported

CFB at Follow-up Month 18

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	39
Obinutuzumab + Bendamustine	76

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.16	11.57	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	4.06	13.36	Not reported	Not reported	Not reported

CFB at Follow-up Month 20

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	33
Obinutuzumab + Bendamustine	73

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-1.21	12.25	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.05	14.29	Not reported	Not reported	Not reported

CFB at Follow-up Month 22

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	28
Obinutuzumab + Bendamustine	71

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.64	14.27	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.80	12.43	Not reported	Not reported	Not reported

CFB at Follow-up Month 24

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	29
Obinutuzumab + Bendamustine	67

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-2.39	9.32	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.28	13.83	Not reported	Not reported	Not reported

CFB at Final Follow-up

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	84
Obinutuzumab + Bendamustine	106

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.50	11.25	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.78	14.94	Not reported	Not reported	Not reported

CFB at Extension Follow Up Month 6

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	21
Obinutuzumab + Bendamustine	60

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.48	8.71	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.74	14.23	Not reported	Not reported	Not reported

CFB at Extension Follow Up Month 18

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	18
Obinutuzumab + Bendamustine	46

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.29	8.40	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	4.56	15.02	Not reported	Not reported	Not reported

CFB at Extension Follow Up Month 24

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	18
Obinutuzumab + Bendamustine	38

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	4.48	11.10	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	4.47	15.22	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16.25
value
79.86
group Id
OG001
spread
16.27
value
80.78
denoms
counts
group Id
OG000
value
185
group Id
OG001
value
186
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
12.28
value
-1.87
group Id
OG001
spread
10.30
value
0.11
denoms
counts
group Id
OG000
value
154
group Id
OG001
value
154
units
Participants
title
CFB at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
9.89
value
-9.37
group Id
OG001
spread
4.98
value
0.52
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
2
units
Participants
title
CFB at Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
12.01
value
-2.44
group Id
OG001
spread
11.13
value
0.06
denoms
counts
group Id
OG000
value
140
group Id
OG001
value
145
units
Participants
title
CFB at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
13.83
value
-1.84
group Id
OG001
spread
11.77
value
-0.92
denoms
counts
group Id
OG000
value
146
group Id
OG001
value
140
units
Participants
title
CFB at End of Induction Treatment
categories
measurements
group Id
OG000
spread
13.42
value
1.53
group Id
OG001
spread
12.01
value
1.22
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
133
units
Participants
title
CFB at Follow-up Month 2
categories
measurements
group Id
OG000
spread
11.47
value
2.55
group Id
OG001
spread
13.00
value
3.06
denoms
counts
group Id
OG000
value
95
group Id
OG001
value
120
units
Participants
title
CFB at Follow-up Month 4
categories
measurements
group Id
OG000
spread
10.68
value
2.54
group Id
OG001
spread
11.40
value
3.24
denoms
counts
group Id
OG000
value
75
group Id
OG001
value
111
units
Participants
title
CFB at Follow-up Month 6
categories
measurements
group Id
OG000
spread
10.15
value
-0.53
group Id
OG001
spread
11.45
value
2.49
denoms
counts
group Id
OG000
value
74
group Id
OG001
value
104
units
Participants
title
CFB at Follow-up Month 8
categories
measurements
group Id
OG000
spread
11.39
value
2.29
group Id
OG001
spread
11.83
value
3.46
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
88
units
Participants
title
CFB at Follow-up Month 10
categories
measurements
group Id
OG000
spread
13.16
value
0.68
group Id
OG001
spread
14.29
value
2.82
denoms
counts
group Id
OG000
value
53
group Id
OG001
value
90
units
Participants
title
CFB at Follow-up Month 12
categories
measurements
group Id
OG000
spread
9.42
value
2.48
group Id
OG001
spread
11.97
value
2.94
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
84
units
Participants
title
CFB at Follow-up Month 14

denoms

counts
group Id
OG000
value
185
group Id
OG001
value
186
units
Participants

description

The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

dispersion Type

Standard Deviation

groups

description
Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
id
OG000
title
Bendamustine Alone
description
Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
id
OG001
title
Obinutuzumab + Bendamustine

param Type

MEAN

population Description

ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

reporting Status

POSTED

time Frame

Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

title

CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Independent clinical review pending · Not medical advice