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NCT01059630 · OUTCOME

CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility 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 utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates 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 + Bendamustine2
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine-0.150.22Not reportedNot reportedNot reported
CFB at Follow-up Month 4

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine119
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.15NANot reportedNot reportedStandard deviation was not evaluable due to low number of participants.
Obinutuzumab + Bendamustine0.030.22Not reportedNot reportedNot reported
CFB at Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine109
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.15NANot reportedNot reportedStandard deviation was not evaluable due to low number of participants.
Obinutuzumab + Bendamustine0.040.19Not reportedNot reportedNot reported
CFB at Follow-up Month 8

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine101
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.15NANot reportedNot reportedStandard deviation is non-evaluable due to low number of participants.
Obinutuzumab + Bendamustine0.040.21Not reportedNot reportedNot reported
CFB at Follow-up Month 10

Analysis denominator · Participants

GroupSource count
Bendamustine Alone1
Obinutuzumab + Bendamustine91
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bendamustine Alone0.15NANot reportedNot reportedStandard deviation was not evaluable due to low number of participants.
Obinutuzumab + Bendamustine0.030.20Not reportedNot reportedNot reported
CFB at Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine87
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.060.18Not reportedNot reportedNot reported
CFB at Follow-up Month 14

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine80
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.060.19Not reportedNot reportedNot reported
CFB at Follow-up Month 16

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine78
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.050.19Not reportedNot reportedNot reported
CFB at Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine73
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.050.18Not reportedNot reportedNot reported
CFB at Follow-up Month 20

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine69
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.050.20Not reportedNot reportedNot reported
CFB at Follow-up Month 22

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine69
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.050.24Not reportedNot reportedNot reported
CFB at Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine64
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.030.22Not reportedNot reportedNot reported
CFB at Final Follow-up

Analysis denominator · Participants

GroupSource count
Bendamustine Alone0
Obinutuzumab + Bendamustine39
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Bendamustine0.030.25Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.22
        value
        -0.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    CFB at Follow-up Month 2
  2. categories
    1. measurements
      1. comment
        Standard deviation was not evaluable due to low number of participants.
        group Id
        OG000
        spread
        NA
        value
        0.15
      2. group Id
        OG001
        spread
        0.22
        value
        0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        119
      units
      Participants
    title
    CFB at Follow-up Month 4
  3. categories
    1. measurements
      1. comment
        Standard deviation was not evaluable due to low number of participants.
        group Id
        OG000
        spread
        NA
        value
        0.15
      2. group Id
        OG001
        spread
        0.19
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    CFB at Follow-up Month 6
  4. categories
    1. measurements
      1. comment
        Standard deviation is non-evaluable due to low number of participants.
        group Id
        OG000
        spread
        NA
        value
        0.15
      2. group Id
        OG001
        spread
        0.21
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        101
      units
      Participants
    title
    CFB at Follow-up Month 8
  5. categories
    1. measurements
      1. comment
        Standard deviation was not evaluable due to low number of participants.
        group Id
        OG000
        spread
        NA
        value
        0.15
      2. group Id
        OG001
        spread
        0.20
        value
        0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    CFB at Follow-up Month 10
  6. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.18
        value
        0.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        87
      units
      Participants
    title
    CFB at Follow-up Month 12
  7. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.19
        value
        0.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        80
      units
      Participants
    title
    CFB at Follow-up Month 14
  8. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.19
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        78
      units
      Participants
    title
    CFB at Follow-up Month 16
  9. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.18
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        73
      units
      Participants
    title
    CFB at Follow-up Month 18
  10. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.20
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    CFB at Follow-up Month 20
  11. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.24
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    CFB at Follow-up Month 22
  12. categories
    1. measurements
      1. group Id
        OG001
        spread
        0.22
        value
        0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        64
      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 utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates 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 EuroQol 5D (EQ-5D) - Health State Profile Utility 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