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NCT01059630 · OUTCOME

CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase

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 and 14

What was measured

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.

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 Alone183
Obinutuzumab + Bendamustine188

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Bendamustine Alone183
Obinutuzumab + Bendamustine188
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone69.4820.71Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine68.0321.69Not reportedNot reportedNot reported
CFB at Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone152
Obinutuzumab + Bendamustine153
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.9119.38Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine3.3215.99Not 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-14.0033.29Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine-4.3342.15Not reportedNot reportedNot reported
CFB at Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Bendamustine Alone136
Obinutuzumab + Bendamustine141
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.3520.79Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.1717.35Not reportedNot reportedNot reported
CFB at End of Induction Treatment

Analysis denominator · Participants

GroupSource count
Bendamustine Alone132
Obinutuzumab + Bendamustine135
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.7161.88Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine5.8222.20Not reportedNot reportedNot reported
CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone36
Obinutuzumab + Bendamustine128
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.1919.12Not reportedNot reportedNot reported
Obinutuzumab + Bendamustine6.8518.95Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.0014.14Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine0
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone10.00NANot reportedNot reportedStandard deviation is non-evaluable due to low number of participants.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.71
        value
        69.48
      2. group Id
        OG001
        spread
        21.69
        value
        68.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      2. group Id
        OG001
        value
        188
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.38
        value
        0.91
      2. group Id
        OG001
        spread
        15.99
        value
        3.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        153
      units
      Participants
    title
    CFB at Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.29
        value
        -14.00
      2. group Id
        OG001
        spread
        42.15
        value
        -4.33
    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
        20.79
        value
        0.35
      2. group Id
        OG001
        spread
        17.35
        value
        5.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        141
      units
      Participants
    title
    CFB at Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.88
        value
        5.71
      2. group Id
        OG001
        spread
        22.20
        value
        5.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        135
      units
      Participants
    title
    CFB at End of Induction Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.12
        value
        5.19
      2. group Id
        OG001
        spread
        18.95
        value
        6.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        128
      units
      Participants
    title
    CFB at Follow-up Month 2
  7. categories
    1. measurements
      1. group Id
        OG001
        spread
        14.14
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    CFB at Follow-up Month 4
  8. categories
    1. measurements
      1. comment
        Standard deviation is non-evaluable due to low number of participants.
        group Id
        OG000
        spread
        NA
        value
        10.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    CFB at Follow-up Month 14
denoms
  1. counts
    1. group Id
      OG000
      value
      183
    2. group Id
      OG001
      value
      188
    units
    Participants
description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.
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 and 14
title
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase
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