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NCT03188536 · OUTCOME

HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)

Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study) · Source last updated 2020-10-12

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
Day 1

What was measured

The 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) with a recall period of previous week. Scores from each subscale were transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. Spanish Translated Version of EORTC Multiple Myeloma Module included 4 factors, each factor corresponds to questions related to the particular component of the scale. Factor I indicate symptoms. Factor II indicates future perspectives. Factor III indicate adverse effects of the treatment. Factor IV indicates adverse effects of the treatment and body image. Each of these factors were used for the clinical validity of the scale.

Analysis population: All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category.

Groups in this outcome

Multiple Myeloma (MM) Participants

Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.

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

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants276

Reported measurements

Future perspective, Factors I-II

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants142
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants60.328.2Not reportedNot reportedNot reported
Future perspective, Factors III

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants53
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants53.924.9Not reportedNot reportedNot reported
Body image, Factors I-II

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants142
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants73.935.5Not reportedNot reportedNot reported
Body image, Factors III

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants53
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants73.032.7Not reportedNot reportedNot reported
Symptoms of the disease, Factors I-II

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants142
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants31.923.6Not reportedNot reportedNot reported
Symptoms of the disease, Factors III

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants53
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants27.322.1Not reportedNot reportedNot reported
Adverse effects of the treatment, Factors I-II

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants142
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants24.316.9Not reportedNot reportedNot reported
Adverse effects of the treatment, Factors III

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Participants53
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Participants29.017.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.2
        value
        60.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Future perspective, Factors I-II
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.9
        value
        53.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Future perspective, Factors III
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.5
        value
        73.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Body image, Factors I-II
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.7
        value
        73.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Body image, Factors III
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.6
        value
        31.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Symptoms of the disease, Factors I-II
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.1
        value
        27.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Symptoms of the disease, Factors III
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.9
        value
        24.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Adverse effects of the treatment, Factors I-II
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.5
        value
        29.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Adverse effects of the treatment, Factors III
denoms
  1. counts
    1. group Id
      OG000
      value
      276
    units
    Participants
description
The 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) with a recall period of previous week. Scores from each subscale were transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. Spanish Translated Version of EORTC Multiple Myeloma Module included 4 factors, each factor corresponds to questions related to the particular component of the scale. Factor I indicate symptoms. Factor II indicates future perspectives. Factor III indicate adverse effects of the treatment. Factor IV indicates adverse effects of the treatment and body image. Each of these factors were used for the clinical validity of the scale.
dispersion Type
Standard Deviation
groups
  1. description
    Adult participants with a diagnosis of MM received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
    id
    OG000
    title
    Multiple Myeloma (MM) Participants
param Type
MEAN
population Description
All participants eligible for analyses were included. Number analyzed is the number of participants with data available for analyses for the specific category.
reporting Status
POSTED
time Frame
Day 1
title
HRQOL Based on the Spanish Translated Version of EORTC Multiple Myeloma Module (EORTC QLQ-MY20)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice