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NCT01059630 · OUTCOME

Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical 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. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (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

GroupSource count
Bendamustine Alone187
Obinutuzumab + Bendamustine187

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Bendamustine Alone187
Obinutuzumab + Bendamustine187
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone22.585.23Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine22.764.61Not reportedNot reportedNot reported
CFB at Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone156
Obinutuzumab + Bendamustine154
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.565.49Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.694.06Not reportedNot reportedNot reported
CFB at Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone5
Obinutuzumab + Bendamustine2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-6.804.21Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-3.002.83Not reportedNot reportedNot reported
CFB at Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone142
Obinutuzumab + Bendamustine145
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.825.06Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.724.16Not reportedNot reportedNot reported
CFB at End of Induction Treatment

Analysis denominator · Participants

GroupSource count
Bendamustine Alone149
Obinutuzumab + Bendamustine142
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.005.14Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.614.62Not reportedNot reportedNot reported
CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone108
Obinutuzumab + Bendamustine133
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.625.14Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.584.45Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone95
Obinutuzumab + Bendamustine121
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.534.58Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.884.47Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone77
Obinutuzumab + Bendamustine112
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.293.74Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.913.82Not reportedNot reportedNot reported
CFB at Follow-up Month 8

Analysis denominator · Participants

GroupSource count
Bendamustine Alone75
Obinutuzumab + Bendamustine104
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.013.53Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.873.96Not reportedNot reportedNot reported
CFB at Follow-up Month 10

Analysis denominator · Participants

GroupSource count
Bendamustine Alone58
Obinutuzumab + Bendamustine91
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.064.16Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.563.81Not reportedNot reportedNot reported
CFB at Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Bendamustine Alone53
Obinutuzumab + Bendamustine90
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.264.02Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.744.24Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone46
Obinutuzumab + Bendamustine85
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.034.14Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.713.94Not reportedNot reportedNot reported
CFB at Follow-up Month 16

Analysis denominator · Participants

GroupSource count
Bendamustine Alone42
Obinutuzumab + Bendamustine82
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.103.49Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.313.68Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone41
Obinutuzumab + Bendamustine76
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.223.64Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.923.99Not reportedNot reportedNot reported
CFB at Follow-up Month 20

Analysis denominator · Participants

GroupSource count
Bendamustine Alone34
Obinutuzumab + Bendamustine73
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.363.70Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.743.69Not reportedNot reportedNot reported
CFB at Follow-up Month 22

Analysis denominator · Participants

GroupSource count
Bendamustine Alone29
Obinutuzumab + Bendamustine71
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.253.93Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.404.47Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone30
Obinutuzumab + Bendamustine68
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.774.16Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.524.42Not reportedNot reportedNot reported
CFB at Final Follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone86
Obinutuzumab + Bendamustine106
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.164.17Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.224.47Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone21
Obinutuzumab + Bendamustine60
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.363.48Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.574.71Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone19
Obinutuzumab + Bendamustine46
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.802.54Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.194.98Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone18
Obinutuzumab + Bendamustine39
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.535.96Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.565.26Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.23
        value
        22.58
      2. group Id
        OG001
        spread
        4.61
        value
        22.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      2. group Id
        OG001
        value
        187
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.49
        value
        -1.56
      2. group Id
        OG001
        spread
        4.06
        value
        -0.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        156
      2. group Id
        OG001
        value
        154
      units
      Participants
    title
    CFB at Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.21
        value
        -6.80
      2. group Id
        OG001
        spread
        2.83
        value
        -3.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    CFB at Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.06
        value
        -1.82
      2. group Id
        OG001
        spread
        4.16
        value
        -0.72
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      2. group Id
        OG001
        value
        145
      units
      Participants
    title
    CFB at Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.14
        value
        -1.00
      2. group Id
        OG001
        spread
        4.62
        value
        -0.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        142
      units
      Participants
    title
    CFB at End of Induction Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.14
        value
        0.62
      2. group Id
        OG001
        spread
        4.45
        value
        0.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        133
      units
      Participants
    title
    CFB at Follow-up Month 2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.58
        value
        0.53
      2. group Id
        OG001
        spread
        4.47
        value
        0.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        121
      units
      Participants
    title
    CFB at Follow-up Month 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.74
        value
        0.29
      2. group Id
        OG001
        spread
        3.82
        value
        0.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        112
      units
      Participants
    title
    CFB at Follow-up Month 6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.53
        value
        -0.01
      2. group Id
        OG001
        spread
        3.96
        value
        0.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    CFB at Follow-up Month 8
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.16
        value
        0.06
      2. group Id
        OG001
        spread
        3.81
        value
        0.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    CFB at Follow-up Month 10
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.02
        value
        0.26
      2. group Id
        OG001
        spread
        4.24
        value
        0.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        90
      units
      Participants
    title
    CFB at Follow-up Month 12
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.14
        value
        0.03
      2. group Id
        OG001
        spread
        3.94
        value
        0.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        85
      units
      Participants
    title
    CFB at Follow-up Month 14
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      187
    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. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (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
  1. 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
  2. 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
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical 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