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NCT01059630 · OUTCOME

CFB in FACT-Lym-Social/Family 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. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). 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

GroupSource count
Bendamustine Alone186
Obinutuzumab + Bendamustine191

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Bendamustine Alone186
Obinutuzumab + Bendamustine191
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone22.045.65Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine22.145.51Not reportedNot reportedNot reported
CFB at Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone155
Obinutuzumab + Bendamustine158
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.213.59Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.103.87Not reportedNot reportedNot reported
CFB at Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone5
Obinutuzumab + Bendamustine3
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.003.67Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine3.112.83Not reportedNot reportedNot reported
CFB at Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone141
Obinutuzumab + Bendamustine149
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.344.32Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.344.33Not reportedNot reportedNot reported
CFB at End of Induction Treatment

Analysis denominator · Participants

GroupSource count
Bendamustine Alone147
Obinutuzumab + Bendamustine145
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.655.21Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.883.60Not reportedNot reportedNot reported
CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone106
Obinutuzumab + Bendamustine137
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.024.83Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.575.37Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone94
Obinutuzumab + Bendamustine125
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.274.65Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.265.02Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone76
Obinutuzumab + Bendamustine114
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.054.46Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.084.64Not reportedNot reportedNot reported
CFB at Follow-up Month 8

Analysis denominator · Participants

GroupSource count
Bendamustine Alone186
Obinutuzumab + Bendamustine191
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.683.67Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.374.99Not reportedNot reportedNot reported
CFB at Follow-up Month 10

Analysis denominator · Participants

GroupSource count
Bendamustine Alone58
Obinutuzumab + Bendamustine94
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.565.00Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.135.14Not reportedNot reportedNot reported
CFB at Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Bendamustine Alone53
Obinutuzumab + Bendamustine93
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.065.89Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.475.64Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone45
Obinutuzumab + Bendamustine89
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.563.28Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.034.16Not reportedNot reportedNot reported
CFB at Follow-up Month 16

Analysis denominator · Participants

GroupSource count
Bendamustine Alone42
Obinutuzumab + Bendamustine85
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.366.79Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.155.28Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone41
Obinutuzumab + Bendamustine78
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.446.23Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.045.35Not reportedNot reportedNot reported
CFB at Follow-up Month 20

Analysis denominator · Participants

GroupSource count
Bendamustine Alone34
Obinutuzumab + Bendamustine76
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.664.28Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.005.75Not reportedNot reportedNot reported
CFB at Follow-up Month 22

Analysis denominator · Participants

GroupSource count
Bendamustine Alone29
Obinutuzumab + Bendamustine74
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.297.12Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.505.02Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone30
Obinutuzumab + Bendamustine71
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.293.91Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.415.24Not reportedNot reportedNot reported
CFB at Final Follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone86
Obinutuzumab + Bendamustine109
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.194.91Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.525.56Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone21
Obinutuzumab + Bendamustine63
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.352.49Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-0.164.92Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone18
Obinutuzumab + Bendamustine49
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.152.92Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.715.26Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone18
Obinutuzumab + Bendamustine40
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.413.18Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.445.02Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.65
        value
        22.04
      2. group Id
        OG001
        spread
        5.51
        value
        22.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        191
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.59
        value
        -0.21
      2. group Id
        OG001
        spread
        3.87
        value
        -0.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        155
      2. group Id
        OG001
        value
        158
      units
      Participants
    title
    CFB at Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.67
        value
        -1.00
      2. group Id
        OG001
        spread
        2.83
        value
        3.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    CFB at Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.32
        value
        -0.34
      2. group Id
        OG001
        spread
        4.33
        value
        -0.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        149
      units
      Participants
    title
    CFB at Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.21
        value
        -0.65
      2. group Id
        OG001
        spread
        3.60
        value
        -0.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        145
      units
      Participants
    title
    CFB at End of Induction Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.83
        value
        -0.02
      2. group Id
        OG001
        spread
        5.37
        value
        -0.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        137
      units
      Participants
    title
    CFB at Follow-up Month 2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.65
        value
        0.27
      2. group Id
        OG001
        spread
        5.02
        value
        -0.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        125
      units
      Participants
    title
    CFB at Follow-up Month 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.46
        value
        0.05
      2. group Id
        OG001
        spread
        4.64
        value
        -0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        114
      units
      Participants
    title
    CFB at Follow-up Month 6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.67
        value
        -0.68
      2. group Id
        OG001
        spread
        4.99
        value
        -0.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        191
      units
      Participants
    title
    CFB at Follow-up Month 8
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.00
        value
        0.56
      2. group Id
        OG001
        spread
        5.14
        value
        0.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    CFB at Follow-up Month 10
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.89
        value
        0.06
      2. group Id
        OG001
        spread
        5.64
        value
        -0.47
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        93
      units
      Participants
    title
    CFB at Follow-up Month 12
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.28
        value
        0.56
      2. group Id
        OG001
        spread
        4.16
        value
        -0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        89
      units
      Participants
    title
    CFB at Follow-up Month 14
denoms
  1. counts
    1. group Id
      OG000
      value
      186
    2. group Id
      OG001
      value
      191
    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. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). 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
  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
CFB in FACT-Lym-Social/Family 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