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NCT01059630 · OUTCOME

CFB in FACT-Lym-Functional 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. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional 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 Alone189
Obinutuzumab + Bendamustine196

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Bendamustine Alone189
Obinutuzumab + Bendamustine196
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone17.986.31Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine17.906.08Not reportedNot reportedNot reported
CFB at Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone157
Obinutuzumab + Bendamustine165
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.544.65Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.384.66Not 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-0.802.28Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.784.91Not reportedNot reportedNot reported
CFB at Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone143
Obinutuzumab + Bendamustine154
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.715.04Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.675.35Not reportedNot reportedNot reported
CFB at End of Induction Treatment

Analysis denominator · Participants

GroupSource count
Bendamustine Alone150
Obinutuzumab + Bendamustine147
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.505.50Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.005.25Not reportedNot reportedNot reported
CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone107
Obinutuzumab + Bendamustine139
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.315.27Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.655.38Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone96
Obinutuzumab + Bendamustine126
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.245.11Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.315.86Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone77
Obinutuzumab + Bendamustine117
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.954.58Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.265.08Not reportedNot reportedNot reported
CFB at Follow-up Month 8

Analysis denominator · Participants

GroupSource count
Bendamustine Alone76
Obinutuzumab + Bendamustine109
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.274.38Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.925.45Not reportedNot reportedNot reported
CFB at Follow-up Month 10

Analysis denominator · Participants

GroupSource count
Bendamustine Alone59
Obinutuzumab + Bendamustine96
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.094.25Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.005.52Not reportedNot reportedNot reported
CFB at Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Bendamustine Alone54
Obinutuzumab + Bendamustine95
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.185.59Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.786.04Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone47
Obinutuzumab + Bendamustine90
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.164.27Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.224.84Not reportedNot reportedNot reported
CFB at Follow-up Month 16

Analysis denominator · Participants

GroupSource count
Bendamustine Alone43
Obinutuzumab + Bendamustine87
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.913.97Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.695.95Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone41
Obinutuzumab + Bendamustine79
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.214.12Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.845.77Not reportedNot reportedNot reported
CFB at Follow-up Month 20

Analysis denominator · Participants

GroupSource count
Bendamustine Alone35
Obinutuzumab + Bendamustine77
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.274.90Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.436.14Not reportedNot reportedNot reported
CFB at Follow-up Month 22

Analysis denominator · Participants

GroupSource count
Bendamustine Alone30
Obinutuzumab + Bendamustine75
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.325.70Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.825.00Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone31
Obinutuzumab + Bendamustine71
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.964.36Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.985.87Not reportedNot reportedNot reported
CFB at Final Follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone84
Obinutuzumab + Bendamustine114
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.084.94Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.506.19Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone23
Obinutuzumab + Bendamustine63
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.013.51Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.856.65Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone19
Obinutuzumab + Bendamustine50
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.964.51Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.906.50Not reportedNot reportedNot reported
CFB at Extension Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone19
Obinutuzumab + Bendamustine42
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone2.223.34Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine2.626.95Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.31
        value
        17.98
      2. group Id
        OG001
        spread
        6.08
        value
        17.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        196
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.65
        value
        -0.54
      2. group Id
        OG001
        spread
        4.66
        value
        0.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        157
      2. group Id
        OG001
        value
        165
      units
      Participants
    title
    CFB at Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.28
        value
        -0.80
      2. group Id
        OG001
        spread
        4.91
        value
        1.78
    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
        5.04
        value
        -0.71
      2. group Id
        OG001
        spread
        5.35
        value
        0.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        154
      units
      Participants
    title
    CFB at Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.50
        value
        -0.50
      2. group Id
        OG001
        spread
        5.25
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        150
      2. group Id
        OG001
        value
        147
      units
      Participants
    title
    CFB at End of Induction Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.27
        value
        0.31
      2. group Id
        OG001
        spread
        5.38
        value
        0.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        139
      units
      Participants
    title
    CFB at Follow-up Month 2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.11
        value
        0.24
      2. group Id
        OG001
        spread
        5.86
        value
        1.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    CFB at Follow-up Month 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.58
        value
        0.95
      2. group Id
        OG001
        spread
        5.08
        value
        1.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    CFB at Follow-up Month 6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.38
        value
        -0.27
      2. group Id
        OG001
        spread
        5.45
        value
        0.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    CFB at Follow-up Month 8
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.25
        value
        1.09
      2. group Id
        OG001
        spread
        5.52
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        96
      units
      Participants
    title
    CFB at Follow-up Month 10
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.59
        value
        0.18
      2. group Id
        OG001
        spread
        6.04
        value
        1.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        95
      units
      Participants
    title
    CFB at Follow-up Month 12
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.27
        value
        1.16
      2. group Id
        OG001
        spread
        4.84
        value
        1.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        90
      units
      Participants
    title
    CFB at Follow-up Month 14
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      196
    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. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional 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-Functional 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