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NCT03433001 · OUTCOME

Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status 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-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores of Global Health Status in EORTC QLQ-C30 were linearly transformed to a total score between 0-100 and reported, with a high score indicating better QOL.

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 + Dexamethasone279

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone279
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone59.9522.472Not reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone75.0011.785Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.472
        value
        59.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        279
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.785
        value
        75.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      279
    units
    Participants
description
EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores of Global Health Status in EORTC QLQ-C30 were linearly transformed to a total score between 0-100 and reported, with a high score indicating better QOL.
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 Health-Related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status Score
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice