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NCT02312258 · OUTCOME

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)

What was measured

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.

Analysis population: ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified time point.

Groups in this outcome

Placebo

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo257
Ixazomib391

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Placebo257
Ixazomib391
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.716.63Not reportedNot reportedNot reported
Ixazomib-0.116.77Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Placebo257
Ixazomib375
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.115.74Not reportedNot reportedNot reported
Ixazomib-1.217.14Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Placebo245
Ixazomib360
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.516.80Not reportedNot reportedNot reported
Ixazomib-0.616.53Not reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
Placebo227
Ixazomib340
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.815.79Not reportedNot reportedNot reported
Ixazomib0.616.33Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Placebo213
Ixazomib307
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.018.33Not reportedNot reportedNot reported
Ixazomib-1.516.56Not reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Placebo202
Ixazomib292
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.116.32Not reportedNot reportedNot reported
Ixazomib-0.717.28Not reportedNot reportedNot reported
Cycle 8

Analysis denominator · Participants

GroupSource count
Placebo186
Ixazomib273
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.918.07Not reportedNot reportedNot reported
Ixazomib-0.417.44Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Placebo173
Ixazomib258
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.416.67Not reportedNot reportedNot reported
Ixazomib0.116.57Not reportedNot reportedNot reported
Cycle 10

Analysis denominator · Participants

GroupSource count
Placebo163
Ixazomib245
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.016.38Not reportedNot reportedNot reported
Ixazomib-1.617.82Not reportedNot reportedNot reported
Cycle 11

Analysis denominator · Participants

GroupSource count
Placebo152
Ixazomib233
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.917.37Not reportedNot reportedNot reported
Ixazomib0.217.75Not reportedNot reportedNot reported
Cycle 12

Analysis denominator · Participants

GroupSource count
Placebo143
Ixazomib228
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.914.53Not reportedNot reportedNot reported
Ixazomib0.316.26Not reportedNot reportedNot reported
Cycle 13

Analysis denominator · Participants

GroupSource count
Placebo132
Ixazomib218
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo4.216.13Not reportedNot reportedNot reported
Ixazomib-0.516.85Not reportedNot reportedNot reported
Cycle 14

Analysis denominator · Participants

GroupSource count
Placebo126
Ixazomib204
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.116.99Not reportedNot reportedNot reported
Ixazomib-1.117.45Not reportedNot reportedNot reported
Cycle 15

Analysis denominator · Participants

GroupSource count
Placebo115
Ixazomib194
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.216.74Not reportedNot reportedNot reported
Ixazomib-0.717.65Not reportedNot reportedNot reported
Cycle 16

Analysis denominator · Participants

GroupSource count
Placebo104
Ixazomib184
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.515.57Not reportedNot reportedNot reported
Ixazomib0.517.03Not reportedNot reportedNot reported
Cycle 17

Analysis denominator · Participants

GroupSource count
Placebo100
Ixazomib182
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.415.09Not reportedNot reportedNot reported
Ixazomib-0.218.09Not reportedNot reportedNot reported
Cycle 18

Analysis denominator · Participants

GroupSource count
Placebo91
Ixazomib182
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.518.40Not reportedNot reportedNot reported
Ixazomib1.716.87Not reportedNot reportedNot reported
Cycle 19

Analysis denominator · Participants

GroupSource count
Placebo82
Ixazomib172
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.618.07Not reportedNot reportedNot reported
Ixazomib1.117.24Not reportedNot reportedNot reported
Cycle 20

Analysis denominator · Participants

GroupSource count
Placebo74
Ixazomib161
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.117.95Not reportedNot reportedNot reported
Ixazomib0.416.13Not reportedNot reportedNot reported
Cycle 21

Analysis denominator · Participants

GroupSource count
Placebo72
Ixazomib153
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.516.39Not reportedNot reportedNot reported
Ixazomib1.316.19Not reportedNot reportedNot reported
Cycle 22

Analysis denominator · Participants

GroupSource count
Placebo72
Ixazomib147
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.615.55Not reportedNot reportedNot reported
Ixazomib1.017.13Not reportedNot reportedNot reported
Cycle 23

Analysis denominator · Participants

GroupSource count
Placebo68
Ixazomib137
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.119.01Not reportedNot reportedNot reported
Ixazomib0.916.96Not reportedNot reportedNot reported
Cycle 24

Analysis denominator · Participants

GroupSource count
Placebo64
Ixazomib132
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.320.46Not reportedNot reportedNot reported
Ixazomib2.315.65Not reportedNot reportedNot reported
Cycle 25

Analysis denominator · Participants

GroupSource count
Placebo56
Ixazomib125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.018.80Not reportedNot reportedNot reported
Ixazomib0.317.52Not reportedNot reportedNot reported
Cycle 26

Analysis denominator · Participants

GroupSource count
Placebo47
Ixazomib106
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.817.49Not reportedNot reportedNot reported
Ixazomib0.917.26Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.63
        value
        1.7
      2. group Id
        OG001
        spread
        16.77
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        257
      2. group Id
        OG001
        value
        391
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.74
        value
        2.1
      2. group Id
        OG001
        spread
        17.14
        value
        -1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        257
      2. group Id
        OG001
        value
        375
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.80
        value
        1.5
      2. group Id
        OG001
        spread
        16.53
        value
        -0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        245
      2. group Id
        OG001
        value
        360
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.79
        value
        1.8
      2. group Id
        OG001
        spread
        16.33
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        227
      2. group Id
        OG001
        value
        340
      units
      Participants
    title
    Cycle 5
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.33
        value
        1.0
      2. group Id
        OG001
        spread
        16.56
        value
        -1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        213
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Cycle 6
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.32
        value
        3.1
      2. group Id
        OG001
        spread
        17.28
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      2. group Id
        OG001
        value
        292
      units
      Participants
    title
    Cycle 7
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.07
        value
        0.9
      2. group Id
        OG001
        spread
        17.44
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        273
      units
      Participants
    title
    Cycle 8
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.67
        value
        1.4
      2. group Id
        OG001
        spread
        16.57
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        173
      2. group Id
        OG001
        value
        258
      units
      Participants
    title
    Cycle 9
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.38
        value
        2.0
      2. group Id
        OG001
        spread
        17.82
        value
        -1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        245
      units
      Participants
    title
    Cycle 10
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.37
        value
        3.9
      2. group Id
        OG001
        spread
        17.75
        value
        0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        233
      units
      Participants
    title
    Cycle 11
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.53
        value
        3.9
      2. group Id
        OG001
        spread
        16.26
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        228
      units
      Participants
    title
    Cycle 12
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.13
        value
        4.2
      2. group Id
        OG001
        spread
        16.85
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        218
      units
      Participants
    title
    Cycle 13
denoms
  1. counts
    1. group Id
      OG000
      value
      257
    2. group Id
      OG001
      value
      391
    units
    Participants
description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    OG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    OG001
    title
    Ixazomib
param Type
MEAN
population Description
ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified time point.
reporting Status
POSTED
time Frame
Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)
title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice