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NCT01059630 · OUTCOME

CFB in FACT-Lym Total 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

FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. 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 Alone186
Obinutuzumab + Bendamustine187

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Bendamustine Alone186
Obinutuzumab + Bendamustine187
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone124.5624.17Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine126.2223.98Not reportedNot reportedNot reported
CFB at Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone153
Obinutuzumab + Bendamustine154
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.7417.91Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.3313.89Not 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-12.1614.80Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine22.5316.23Not reportedNot reportedNot reported
CFB at Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone140
Obinutuzumab + Bendamustine144
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-1.6816.61Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine1.7115.23Not reportedNot reportedNot reported
CFB at End of Induction Treatment

Analysis denominator · Participants

GroupSource count
Bendamustine Alone147
Obinutuzumab + Bendamustine140
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.0218.55Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine0.3518.29Not reportedNot reportedNot reported
CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone106
Obinutuzumab + Bendamustine131
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.1017.73Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine3.5415.45Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone95
Obinutuzumab + Bendamustine119
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.4016.29Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.5017.76Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone76
Obinutuzumab + Bendamustine113
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.0315.01Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.5715.96Not reportedNot reportedNot reported
CFB at Follow-up Month 8

Analysis denominator · Participants

GroupSource count
Bendamustine Alone74
Obinutuzumab + Bendamustine104
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone1.4814.27Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.1815.61Not 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 Alone4.5816.39Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.7016.89Not reportedNot reportedNot reported
CFB at Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Bendamustine Alone52
Obinutuzumab + Bendamustine91
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone2.9717.84Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.8818.93Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone45
Obinutuzumab + Bendamustine87
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone3.1813.85Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.9217.06Not reportedNot reportedNot reported
CFB at Follow-up Month 16

Analysis denominator · Participants

GroupSource count
Bendamustine Alone41
Obinutuzumab + Bendamustine83
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone2.2514.98Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine7.5916.97Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone40
Obinutuzumab + Bendamustine76
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone2.1615.38Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.9918.27Not reportedNot reportedNot reported
CFB at Follow-up Month 20

Analysis denominator · Participants

GroupSource count
Bendamustine Alone33
Obinutuzumab + Bendamustine73
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-0.8916.34Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.6618.90Not 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 Alone2.1519.03Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine4.5917.98Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone30
Obinutuzumab + Bendamustine67
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-2.1315.74Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.2818.75Not reportedNot reportedNot reported
CFB at Final follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone84
Obinutuzumab + Bendamustine105
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone2.1516.60Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine2.5520.11Not 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 Alone1.2211.67Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.1420.30Not reportedNot reportedNot reported
CFB at Extension Follow Up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone18
Obinutuzumab + Bendamustine48
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone4.9214.73Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.8819.24Not reportedNot reportedNot reported
CFB at Extension Follow Up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone18
Obinutuzumab + Bendamustine41
Values in Units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone9.6915.88Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.1320.32Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.17
        value
        124.56
      2. group Id
        OG001
        spread
        23.98
        value
        126.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        187
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.91
        value
        -0.74
      2. group Id
        OG001
        spread
        13.89
        value
        1.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        153
      2. group Id
        OG001
        value
        154
      units
      Participants
    title
    CFB at Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.80
        value
        -12.16
      2. group Id
        OG001
        spread
        16.23
        value
        22.53
    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
        16.61
        value
        -1.68
      2. group Id
        OG001
        spread
        15.23
        value
        1.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        140
      2. group Id
        OG001
        value
        144
      units
      Participants
    title
    CFB at Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.55
        value
        0.02
      2. group Id
        OG001
        spread
        18.29
        value
        0.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        140
      units
      Participants
    title
    CFB at End of Induction Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.73
        value
        5.10
      2. group Id
        OG001
        spread
        15.45
        value
        3.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    CFB at Follow-up Month 2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.29
        value
        5.40
      2. group Id
        OG001
        spread
        17.76
        value
        5.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        119
      units
      Participants
    title
    CFB at Follow-up Month 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.01
        value
        5.03
      2. group Id
        OG001
        spread
        15.96
        value
        6.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        113
      units
      Participants
    title
    CFB at Follow-up Month 6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.27
        value
        1.48
      2. group Id
        OG001
        spread
        15.61
        value
        5.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    CFB at Follow-up Month 8
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.39
        value
        4.58
      2. group Id
        OG001
        spread
        16.89
        value
        5.70
    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
        17.84
        value
        2.97
      2. group Id
        OG001
        spread
        18.93
        value
        5.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    CFB at Follow-up Month 12
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.85
        value
        3.18
      2. group Id
        OG001
        spread
        17.06
        value
        5.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        87
      units
      Participants
    title
    CFB at Follow-up Month 14
denoms
  1. counts
    1. group Id
      OG000
      value
      186
    2. group Id
      OG001
      value
      187
    units
    Participants
description
FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. 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 Total 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