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NCT03433001 · OUTCOME

Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score

A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone · Source last updated 2023-12-07

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 and End of Treatment (Up to 37 cycles, each cycle was of 28 days)

What was measured

EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.

Analysis population: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.

Groups in this outcome

Ixazomib + Lenalidomide + Dexamethasone

Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.

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

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone278

Reported measurements

Disease Symptoms: Baseline

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone278
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone19.3318.949Not reportedNot reportedNot reported
Disease Symptoms: End of Treatment

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone11.117.857Not reportedNot reportedNot reported
Side-Effects of Treatment: Baseline

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone278
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone17.8013.903Not reportedNot reportedNot reported
Side-Effects of Treatment: End of Treatment

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone16.677.857Not reportedNot reportedNot reported
Body Image: Baseline

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone278
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone28.1830.397Not reportedNot reportedNot reported
Body Image: End of Treatment

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone16.6723.570Not reportedNot reportedNot reported
Future Perspective: Baseline

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone278
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone42.4925.634Not reportedNot reportedNot reported
Future Perspective: End of Treatment

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone33.330.000Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.949
        value
        19.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        278
      units
      Participants
    title
    Disease Symptoms: Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.857
        value
        11.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Disease Symptoms: End of Treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.903
        value
        17.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        278
      units
      Participants
    title
    Side-Effects of Treatment: Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.857
        value
        16.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Side-Effects of Treatment: End of Treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.397
        value
        28.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        278
      units
      Participants
    title
    Body Image: Baseline
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.570
        value
        16.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Body Image: End of Treatment
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.634
        value
        42.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        278
      units
      Participants
    title
    Future Perspective: Baseline
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.000
        value
        33.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Future Perspective: End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      278
    units
    Participants
description
EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.
dispersion Type
Standard Deviation
groups
  1. description
    Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
    id
    OG000
    title
    Ixazomib + Lenalidomide + Dexamethasone
param Type
MEAN
population Description
Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
reporting Status
POSTED
time Frame
Baseline and End of Treatment (Up to 37 cycles, each cycle was of 28 days)
title
Patient-Reported Outcome HRQoL Based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
type
SECONDARY
unit Of Measure
Score on a Scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice