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NCT01059630 · OUTCOME

CFB in EQ-5D VAS Score During Maintenance 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, 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) (end of induction = up to Month 6)

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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.

Analysis population: ITT population (Obinutuzumab + Bendamustine arm only). 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 Alone2
Obinutuzumab + Bendamustine158

Reported measurements

CFB at Follow-up Month 2

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine-40.00NANot reportedNot reportedSD data not applicable as only one participant was evaluable for this time point.
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine111
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.00NANot reportedNot reportedSD data not applicable as only one participant was evaluable for this time point.
Obinutuzumab + Bendamustine5.5919.61Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine106
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.00NANot reportedNot reportedSD data not applicable as only one participant was evaluable for this time point.
Obinutuzumab + Bendamustine6.0419.00Not reportedNot reportedNot reported
CFB at Follow-up Month 8

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine95
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone5.00NANot reportedNot reportedSD data not applicable as only one participant was evaluable for this time point.
Obinutuzumab + Bendamustine4.7917.18Not reportedNot reportedNot reported
CFB at Follow-up Month 10

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine86
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone-15.00NANot reportedNot reportedSD data not applicable as only one participant was evaluable for this time point.
Obinutuzumab + Bendamustine4.6216.28Not reportedNot reportedNot reported
CFB at Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine82
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine5.7316.04Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine77
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine5.4517.36Not reportedNot reportedNot reported
CFB at Follow-up Month 16

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine76
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine6.6617.44Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine69
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine6.1319.44Not reportedNot reportedNot reported
CFB at Follow-up Month 20

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine66
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine7.5615.43Not reportedNot reportedNot reported
CFB at Follow-up Month 22

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine64
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine6.9715.55Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine61
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine8.2816.23Not reportedNot reportedNot reported
CFB at Final Follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine38
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine4.4714.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        SD data not applicable as only one participant was evaluable for this time point.
        group Id
        OG001
        spread
        NA
        value
        -40.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    CFB at Follow-up Month 2
  2. categories
    1. measurements
      1. comment
        SD data not applicable as only one participant was evaluable for this time point.
        group Id
        OG000
        spread
        NA
        value
        5.00
      2. group Id
        OG001
        spread
        19.61
        value
        5.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        111
      units
      Participants
    title
    CFB at Follow-up Month 4
  3. categories
    1. measurements
      1. comment
        SD data not applicable as only one participant was evaluable for this time point.
        group Id
        OG000
        spread
        NA
        value
        5.00
      2. group Id
        OG001
        spread
        19.00
        value
        6.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        106
      units
      Participants
    title
    CFB at Follow-up Month 6
  4. categories
    1. measurements
      1. comment
        SD data not applicable as only one participant was evaluable for this time point.
        group Id
        OG000
        spread
        NA
        value
        5.00
      2. group Id
        OG001
        spread
        17.18
        value
        4.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        95
      units
      Participants
    title
    CFB at Follow-up Month 8
  5. categories
    1. measurements
      1. comment
        SD data not applicable as only one participant was evaluable for this time point.
        group Id
        OG000
        spread
        NA
        value
        -15.00
      2. group Id
        OG001
        spread
        16.28
        value
        4.62
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        86
      units
      Participants
    title
    CFB at Follow-up Month 10
  6. categories
    1. measurements
      1. group Id
        OG001
        spread
        16.04
        value
        5.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        82
      units
      Participants
    title
    CFB at Follow-up Month 12
  7. categories
    1. measurements
      1. group Id
        OG001
        spread
        17.36
        value
        5.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        77
      units
      Participants
    title
    CFB at Follow-up Month 14
  8. categories
    1. measurements
      1. group Id
        OG001
        spread
        17.44
        value
        6.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        76
      units
      Participants
    title
    CFB at Follow-up Month 16
  9. categories
    1. measurements
      1. group Id
        OG001
        spread
        19.44
        value
        6.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    CFB at Follow-up Month 18
  10. categories
    1. measurements
      1. group Id
        OG001
        spread
        15.43
        value
        7.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    CFB at Follow-up Month 20
  11. categories
    1. measurements
      1. group Id
        OG001
        spread
        15.55
        value
        6.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        64
      units
      Participants
    title
    CFB at Follow-up Month 22
  12. categories
    1. measurements
      1. group Id
        OG001
        spread
        16.23
        value
        8.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        61
      units
      Participants
    title
    CFB at Follow-up Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      158
    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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
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 (Obinutuzumab + Bendamustine arm only). 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, 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) (end of induction = up to Month 6)
title
CFB in EQ-5D VAS Score During Maintenance 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