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NCT01059630 · OUTCOME

CFB in FACT-Lym-Emotional Well-Being 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. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). 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	189
Obinutuzumab + Bendamustine	193

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	189
Obinutuzumab + Bendamustine	193

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	17.38	4.45	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	17.81	4.33	Not reported	Not reported	Not reported

CFB at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	157
Obinutuzumab + Bendamustine	163

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.61	3.04	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.78	3.14	Not reported	Not reported	Not reported

CFB at Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	5
Obinutuzumab + Bendamustine	3

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-0.60	3.85	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	3.40	4.42	Not reported	Not reported	Not reported

CFB at Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	143
Obinutuzumab + Bendamustine	152

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.37	3.08	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.50	3.52	Not reported	Not reported	Not reported

CFB at End of Induction Treatment

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	149
Obinutuzumab + Bendamustine	145

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.53	3.57	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.59	4.03	Not reported	Not reported	Not reported

CFB at Follow-up Month 2

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	107
Obinutuzumab + Bendamustine	138

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.66	3.89	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.67	3.83	Not reported	Not reported	Not reported

CFB at Follow-up Month 4

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	96
Obinutuzumab + Bendamustine	124

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	1.34	3.54	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.95	3.51	Not reported	Not reported	Not reported

CFB at Follow-up Month 6

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	78
Obinutuzumab + Bendamustine	116

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.89	3.57	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.96	3.44	Not reported	Not reported	Not reported

CFB at Follow-up Month 8

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	76
Obinutuzumab + Bendamustine	108

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.26	3.35	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.97	3.34	Not reported	Not reported	Not reported

CFB at Follow-up Month 10

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	58
Obinutuzumab + Bendamustine	94

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.69	3.31	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.32	3.23	Not reported	Not reported	Not reported

CFB at Follow-up Month 12

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	54
Obinutuzumab + Bendamustine	93

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-0.07	3.88	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.95	3.29	Not reported	Not reported	Not reported

CFB at Follow-up Month 14

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	47
Obinutuzumab + Bendamustine	89

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.46	3.22	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.07	3.82	Not reported	Not reported	Not reported

CFB at Follow-up Month 16

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	43
Obinutuzumab + Bendamustine	86

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.13	3.87	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.04	3.69	Not reported	Not reported	Not reported

CFB at Follow-up Month 18

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	41
Obinutuzumab + Bendamustine	79

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.42	3.36	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.00	3.38	Not reported	Not reported	Not reported

CFB at Follow-up Month 20

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	35
Obinutuzumab + Bendamustine	76

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-0.43	2.90	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.94	4.28	Not reported	Not reported	Not reported

CFB at Follow-up Month 22

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	30
Obinutuzumab + Bendamustine	74

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.18	2.81	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.97	3.79	Not reported	Not reported	Not reported

CFB at Follow-up Month 24

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	31
Obinutuzumab + Bendamustine	71

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.06	3.20	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	1.12	3.78	Not reported	Not reported	Not reported

CFB at Final Follow-up

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	84
Obinutuzumab + Bendamustine	111

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	0.38	3.77	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.34	4.37	Not reported	Not reported	Not reported

CFB at Extension Follow-up Month 6

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	23
Obinutuzumab + Bendamustine	63

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	-0.44	3.26	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.39	3.99	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	-0.08	3.80	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.75	3.85	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	1.04	4.16	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	0.97	4.36	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
4.45
value
17.38
group Id
OG001
spread
4.33
value
17.81
denoms
counts
group Id
OG000
value
189
group Id
OG001
value
193
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
3.04
value
0.61
group Id
OG001
spread
3.14
value
0.78
denoms
counts
group Id
OG000
value
157
group Id
OG001
value
163
units
Participants
title
CFB at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
3.85
value
-0.60
group Id
OG001
spread
4.42
value
3.40
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
3
units
Participants
title
CFB at Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
3.08
value
0.37
group Id
OG001
spread
3.52
value
0.50
denoms
counts
group Id
OG000
value
143
group Id
OG001
value
152
units
Participants
title
CFB at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
3.57
value
0.53
group Id
OG001
spread
4.03
value
0.59
denoms
counts
group Id
OG000
value
149
group Id
OG001
value
145
units
Participants
title
CFB at End of Induction Treatment
categories
measurements
group Id
OG000
spread
3.89
value
0.66
group Id
OG001
spread
3.83
value
0.67
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
138
units
Participants
title
CFB at Follow-up Month 2
categories
measurements
group Id
OG000
spread
3.54
value
1.34
group Id
OG001
spread
3.51
value
0.95
denoms
counts
group Id
OG000
value
96
group Id
OG001
value
124
units
Participants
title
CFB at Follow-up Month 4
categories
measurements
group Id
OG000
spread
3.57
value
0.89
group Id
OG001
spread
3.44
value
0.96
denoms
counts
group Id
OG000
value
78
group Id
OG001
value
116
units
Participants
title
CFB at Follow-up Month 6
categories
measurements
group Id
OG000
spread
3.35
value
0.26
group Id
OG001
spread
3.34
value
0.97
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
108
units
Participants
title
CFB at Follow-up Month 8
categories
measurements
group Id
OG000
spread
3.31
value
0.69
group Id
OG001
spread
3.23
value
1.32
denoms
counts
group Id
OG000
value
58
group Id
OG001
value
94
units
Participants
title
CFB at Follow-up Month 10
categories
measurements
group Id
OG000
spread
3.88
value
-0.07
group Id
OG001
spread
3.29
value
0.95
denoms
counts
group Id
OG000
value
54
group Id
OG001
value
93
units
Participants
title
CFB at Follow-up Month 12
categories
measurements
group Id
OG000
spread
3.22
value
0.46
group Id
OG001
spread
3.82
value
1.07
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
89
units
Participants
title
CFB at Follow-up Month 14

denoms

counts
group Id
OG000
value
189
group Id
OG001
value
193
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. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). 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 FACT-Lym-Emotional Well-Being 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