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NCT01059630 · OUTCOME

CFB in FACT-Lym Trial Outcome Index (TOI)

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

TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. 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.

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 Alone190
Obinutuzumab + Bendamustine196

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Bendamustine Alone190
Obinutuzumab + Bendamustine196
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone84.6619.36Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine84.7618.97Not reportedNot reportedNot reported
CFB at Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone159
Obinutuzumab + Bendamustine165
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.9417.96Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.8113.88Not 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-10.4010.38Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine26.4419.51Not reportedNot reportedNot reported
CFB at Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone144
Obinutuzumab + Bendamustine154
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.3815.38Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine2.3714.15Not reportedNot reportedNot reported
CFB at End of Induction Treatment

Analysis denominator · Participants

GroupSource count
Bendamustine Alone151
Obinutuzumab + Bendamustine149
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.5217.23Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.4016.45Not reportedNot reportedNot reported
CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone108
Obinutuzumab + Bendamustine139
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone3.7515.36Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine4.6014.85Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone96
Obinutuzumab + Bendamustine127
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone3.8113.39Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.1817.06Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone79
Obinutuzumab + Bendamustine117
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone3.2612.19Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.0713.72Not 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 Alone1.3612.39Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.3614.21Not 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 Alone3.5213.16Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine4.9415.96Not 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 Alone2.0515.14Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.1315.72Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone47
Obinutuzumab + Bendamustine91
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone2.2511.92Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.1314.30Not 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 Alone0.7514.15Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.7815.11Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone42
Obinutuzumab + Bendamustine79
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.3611.30Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine7.2614.62Not 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-0.6415.21Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.3614.99Not 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 Alone2.2614.54Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.3017.88Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone31
Obinutuzumab + Bendamustine72
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.1413.44Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.3017.88Not reportedNot reportedNot reported
CFB at Final Follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone86
Obinutuzumab + Bendamustine114
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.8414.80Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine3.8416.22Not 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 Alone2.3010.77Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.5318.44Not reportedNot reportedNot reported
CFB at Extension Follow Up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone20
Obinutuzumab + Bendamustine50
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone4.0214.01Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine7.3115.69Not 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 Alone10.0413.35Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine7.0717.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.36
        value
        84.66
      2. group Id
        OG001
        spread
        18.97
        value
        84.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      2. group Id
        OG001
        value
        196
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.96
        value
        -1.94
      2. group Id
        OG001
        spread
        13.88
        value
        1.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        165
      units
      Participants
    title
    CFB at Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.38
        value
        -10.40
      2. group Id
        OG001
        spread
        19.51
        value
        26.44
    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
        15.38
        value
        -1.38
      2. group Id
        OG001
        spread
        14.15
        value
        2.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        144
      2. group Id
        OG001
        value
        154
      units
      Participants
    title
    CFB at Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.23
        value
        -0.52
      2. group Id
        OG001
        spread
        16.45
        value
        0.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        149
      units
      Participants
    title
    CFB at End of Induction Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.36
        value
        3.75
      2. group Id
        OG001
        spread
        14.85
        value
        4.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        139
      units
      Participants
    title
    CFB at Follow-up Month 2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.39
        value
        3.81
      2. group Id
        OG001
        spread
        17.06
        value
        5.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        127
      units
      Participants
    title
    CFB at Follow-up Month 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.19
        value
        3.26
      2. group Id
        OG001
        spread
        13.72
        value
        6.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    CFB at Follow-up Month 6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.39
        value
        1.36
      2. group Id
        OG001
        spread
        14.21
        value
        5.36
    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
        13.16
        value
        3.52
      2. group Id
        OG001
        spread
        15.96
        value
        4.94
    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
        15.14
        value
        2.05
      2. group Id
        OG001
        spread
        15.72
        value
        6.13
    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
        11.92
        value
        2.25
      2. group Id
        OG001
        spread
        14.30
        value
        5.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    CFB at Follow-up Month 14
denoms
  1. counts
    1. group Id
      OG000
      value
      190
    2. group Id
      OG001
      value
      196
    units
    Participants
description
TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. 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.
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 Trial Outcome Index (TOI)
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