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NCT01059630 · OUTCOME

CFB in FACT-Lym-Lymphoma Sub-scale 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-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). 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.

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	189
Obinutuzumab + Bendamustine	194

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	189
Obinutuzumab + Bendamustine	194

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	44.79	9.66	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	45.61	9.17	Not reported	Not reported	Not reported

CFB at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	154
Obinutuzumab + Bendamustine	162

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.98	6.97	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.24	5.71	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	-2.80	5.76	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	9.50	3.54	Not reported	Not reported	Not reported

CFB at Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	142
Obinutuzumab + Bendamustine	151

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.75	6.79	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.41	6.21	Not reported	Not reported	Not reported

CFB at End of Induction Treatment

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	148
Obinutuzumab + Bendamustine	148

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.64	7.10	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.74	7.89	Not reported	Not reported	Not reported

CFB at Follow-up Month 2

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	107
Obinutuzumab + Bendamustine	135

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	3.44	6.78	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.45	6.22	Not reported	Not reported	Not reported

CFB at Follow-up Month 4

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	96
Obinutuzumab + Bendamustine	123

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.77	6.71	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.39	6.54	Not reported	Not reported	Not reported

CFB at Follow-up Month 6

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	79
Obinutuzumab + Bendamustine	117

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.33	6.44	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.00	7.05	Not reported	Not reported	Not reported

CFB at Follow-up Month 8

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	75
Obinutuzumab + Bendamustine	107

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.79	6.01	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.52	6.69	Not reported	Not reported	Not reported

CFB at Follow-up Month 10

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	59
Obinutuzumab + Bendamustine	94

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.90	6.78	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.28	6.82	Not reported	Not reported	Not reported

CFB at Follow-up Month 12

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	53
Obinutuzumab + Bendamustine	94

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	2.12	6.47	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.89	6.42	Not reported	Not reported	Not reported

CFB at Follow-up Month 14

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	47
Obinutuzumab + Bendamustine	91

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.48	6.64	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.58	6.37	Not reported	Not reported	Not reported

CFB at Follow-up Month 16

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	42
Obinutuzumab + Bendamustine	86

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.44	7.79	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.27	6.14	Not reported	Not reported	Not reported

CFB at Follow-up Month 18

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	42
Obinutuzumab + Bendamustine	78

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.18	6.09	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.91	6.79	Not reported	Not reported	Not reported

CFB at Follow-up Month 20

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	34
Obinutuzumab + Bendamustine	75

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.57	7.43	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.83	6.41	Not reported	Not reported	Not reported

CFB at Follow-up Month 22

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	30
Obinutuzumab + Bendamustine	72

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.89	8.62	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.55	6.58	Not reported	Not reported	Not reported

CFB at Follow-up Month 24

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	31
Obinutuzumab + Bendamustine	70

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.66	7.59	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.73	6.48	Not reported	Not reported	Not reported

CFB at Final Follow-up

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	85
Obinutuzumab + Bendamustine	112

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.62	7.17	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.33	7.38	Not reported	Not reported	Not reported

CFB at Extension Follow-up Month 6

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	23
Obinutuzumab + Bendamustine	61

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.92	5.06	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.98	7.22	Not reported	Not reported	Not reported

CFB at Extension Follow-up Month 18

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	20
Obinutuzumab + Bendamustine	50

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.80	8.30	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.35	5.72	Not reported	Not reported	Not reported

CFB at Extension Follow-up Month 24

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	19
Obinutuzumab + Bendamustine	42

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	4.89	6.67	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	2.23	6.85	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
9.66
value
44.79
group Id
OG001
spread
9.17
value
45.61
denoms
counts
group Id
OG000
value
189
group Id
OG001
value
194
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
6.97
value
0.98
group Id
OG001
spread
5.71
value
1.24
denoms
counts
group Id
OG000
value
154
group Id
OG001
value
162
units
Participants
title
CFB at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
5.76
value
-2.80
group Id
OG001
spread
3.54
value
9.50
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
6.79
value
0.75
group Id
OG001
spread
6.21
value
1.41
denoms
counts
group Id
OG000
value
142
group Id
OG001
value
151
units
Participants
title
CFB at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
7.10
value
1.64
group Id
OG001
spread
7.89
value
0.74
denoms
counts
group Id
OG000
value
148
group Id
OG001
value
148
units
Participants
title
CFB at End of Induction Treatment
categories
measurements
group Id
OG000
spread
6.78
value
3.44
group Id
OG001
spread
6.22
value
2.45
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
135
units
Participants
title
CFB at Follow-up Month 2
categories
measurements
group Id
OG000
spread
6.71
value
2.77
group Id
OG001
spread
6.54
value
2.39
denoms
counts
group Id
OG000
value
96
group Id
OG001
value
123
units
Participants
title
CFB at Follow-up Month 4
categories
measurements
group Id
OG000
spread
6.44
value
2.33
group Id
OG001
spread
7.05
value
3.00
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
117
units
Participants
title
CFB at Follow-up Month 6
categories
measurements
group Id
OG000
spread
6.01
value
1.79
group Id
OG001
spread
6.69
value
2.52
denoms
counts
group Id
OG000
value
75
group Id
OG001
value
107
units
Participants
title
CFB at Follow-up Month 8
categories
measurements
group Id
OG000
spread
6.78
value
1.90
group Id
OG001
spread
6.82
value
2.28
denoms
counts
group Id
OG000
value
59
group Id
OG001
value
94
units
Participants
title
CFB at Follow-up Month 10
categories
measurements
group Id
OG000
spread
6.47
value
2.12
group Id
OG001
spread
6.42
value
2.89
denoms
counts
group Id
OG000
value
53
group Id
OG001
value
94
units
Participants
title
CFB at Follow-up Month 12
categories
measurements
group Id
OG000
spread
6.64
value
0.48
group Id
OG001
spread
6.37
value
2.58
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
91
units
Participants
title
CFB at Follow-up Month 14

denoms

counts
group Id
OG000
value
189
group Id
OG001
value
194
units
Participants

description

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). 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.

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 FACT-Lym-Lymphoma Sub-scale 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