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NCT01059630 · OUTCOME

Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)

What was measured

FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).

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	209
Obinutuzumab + Bendamustine	204

Reported measurements

C5D1 (>=3 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	155
Obinutuzumab + Bendamustine	156

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	30.3	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	41.7	Not reported	Not reported	Not reported	Not reported

FUM6 (>=3 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	87
Obinutuzumab + Bendamustine	119

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	37.9	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	47.1	Not reported	Not reported	Not reported	Not reported

FUM12 (>=3 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	60
Obinutuzumab + Bendamustine	99

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	36.7	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	46.5	Not reported	Not reported	Not reported	Not reported

FUM18 (>=3 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	45
Obinutuzumab + Bendamustine	83

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	35.6	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	53.0	Not reported	Not reported	Not reported	Not reported

FUM24 (>=3 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	34
Obinutuzumab + Bendamustine	74

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	35.3	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	50	Not reported	Not reported	Not reported	Not reported

Ext FUM6 (>=3 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	25
Obinutuzumab + Bendamustine	64

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	36.0	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	57.8	Not reported	Not reported	Not reported	Not reported

C5D1 (>=6 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	156
Obinutuzumab + Bendamustine	157

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	23.1	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	34.4	Not reported	Not reported	Not reported	Not reported

FUM6 (>=6 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	88
Obinutuzumab + Bendamustine	119

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	29.5	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	43.7	Not reported	Not reported	Not reported	Not reported

FUM12 (>=6 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	61
Obinutuzumab + Bendamustine	100

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	26.2	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	47.0	Not reported	Not reported	Not reported	Not reported

FUM18 (>=6 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	45
Obinutuzumab + Bendamustine	83

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	28.9	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	51.8	Not reported	Not reported	Not reported	Not reported

FUM24 (>=6 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	34
Obinutuzumab + Bendamustine	75

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	26.5	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	48.0	Not reported	Not reported	Not reported	Not reported

Ext FUM6 (>=6 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	25
Obinutuzumab + Bendamustine	65

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	44	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	56.9	Not reported	Not reported	Not reported	Not reported

C5D1 (>=7 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	156
Obinutuzumab + Bendamustine	157

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	24.4	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	28.0	Not reported	Not reported	Not reported	Not reported

FUM6 (>=7 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	88
Obinutuzumab + Bendamustine	119

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	34.1	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	40.3	Not reported	Not reported	Not reported	Not reported

FUM12 (>=7 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	61
Obinutuzumab + Bendamustine	100

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	31.1	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	45.0	Not reported	Not reported	Not reported	Not reported

FUM18 (>=7 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	45
Obinutuzumab + Bendamustine	83

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	31.1	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	43.4	Not reported	Not reported	Not reported	Not reported

FUM24 (>=7 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	34
Obinutuzumab + Bendamustine	75

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	20.6	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	42.7	Not reported	Not reported	Not reported	Not reported

Ext FUM6 (>=7 pt increase)

Analysis denominator · Participants

Group	Source count
Bendamustine Alone	25
Obinutuzumab + Bendamustine	65

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Bendamustine Alone	32	Not reported	Not reported	Not reported	Not reported
Obinutuzumab + Bendamustine	47.7	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
30.3
group Id
OG001
value
41.7
denoms
counts
group Id
OG000
value
155
group Id
OG001
value
156
units
Participants
title
C5D1 (>=3 pt increase)
categories
measurements
group Id
OG000
value
37.9
group Id
OG001
value
47.1
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
119
units
Participants
title
FUM6 (>=3 pt increase)
categories
measurements
group Id
OG000
value
36.7
group Id
OG001
value
46.5
denoms
counts
group Id
OG000
value
60
group Id
OG001
value
99
units
Participants
title
FUM12 (>=3 pt increase)
categories
measurements
group Id
OG000
value
35.6
group Id
OG001
value
53.0
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
83
units
Participants
title
FUM18 (>=3 pt increase)
categories
measurements
group Id
OG000
value
35.3
group Id
OG001
value
50
denoms
counts
group Id
OG000
value
34
group Id
OG001
value
74
units
Participants
title
FUM24 (>=3 pt increase)
categories
measurements
group Id
OG000
value
36.0
group Id
OG001
value
57.8
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
64
units
Participants
title
Ext FUM6 (>=3 pt increase)
categories
measurements
group Id
OG000
value
23.1
group Id
OG001
value
34.4
denoms
counts
group Id
OG000
value
156
group Id
OG001
value
157
units
Participants
title
C5D1 (>=6 pt increase)
categories
measurements
group Id
OG000
value
29.5
group Id
OG001
value
43.7
denoms
counts
group Id
OG000
value
88
group Id
OG001
value
119
units
Participants
title
FUM6 (>=6 pt increase)
categories
measurements
group Id
OG000
value
26.2
group Id
OG001
value
47.0
denoms
counts
group Id
OG000
value
61
group Id
OG001
value
100
units
Participants
title
FUM12 (>=6 pt increase)
categories
measurements
group Id
OG000
value
28.9
group Id
OG001
value
51.8
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
83
units
Participants
title
FUM18 (>=6 pt increase)
categories
measurements
group Id
OG000
value
26.5
group Id
OG001
value
48.0
denoms
counts
group Id
OG000
value
34
group Id
OG001
value
75
units
Participants
title
FUM24 (>=6 pt increase)
categories
measurements
group Id
OG000
value
44
group Id
OG001
value
56.9
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
65
units
Participants
title
Ext FUM6 (>=6 pt increase)

denoms

counts
group Id
OG000
value
209
group Id
OG001
value
204
units
Participants

description

FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).

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

NUMBER

population Description

ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.

reporting Status

POSTED

time Frame

Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)

title

Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores

type

SECONDARY

unit Of Measure

Percentage of participants

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

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