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NCT03682536 · OUTCOME

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

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 week 24.

What was measured

The EORTC QLQ-C30 is composed of 30 items that includes a global health status score ranging from: 1-7 as well as scores for 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, nausea/vomiting, and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) all ranging from 1-4. Subscale scores are transformed to a 0 to 100 scale. A high score for a functional scale represents a high or healthy level of functioning; a high score for the global health status/health related quality of life (HRQoL) represents a high overall HRQoL; but a high score for a symptom scale represents a high level of symptomatology or problems. Baseline is defined as the last value on or before the first dose of study drug.

Analysis population: All randomized participants who completed the EORTC QLQ-C30 assessment at baseline and post-baseline assessment at the respective visit.

Groups in this outcome

Luspatercept

Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

Epoetin Alfa

Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

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

Analysis denominator · Participants

GroupSource count
Luspatercept125
Epoetin Alfa110

Reported measurements

Global Health Status / QoL
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept1.716.70Not reportedNot reportedNot reported
Epoetin Alfa2.720.99Not reportedNot reportedNot reported
Physical Functioning
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept0.116.32Not reportedNot reportedNot reported
Epoetin Alfa4.418.30Not reportedNot reportedNot reported
Role Functioning
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-1.925.59Not reportedNot reportedNot reported
Epoetin Alfa-2.626.92Not reportedNot reportedNot reported
Emotional Functioning
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept2.517.17Not reportedNot reportedNot reported
Epoetin Alfa3.418.32Not reportedNot reportedNot reported
Cognitive Functioning
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept2.017.79Not reportedNot reportedNot reported
Epoetin Alfa0.220.75Not reportedNot reportedNot reported
Social Functioning
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-2.920.64Not reportedNot reportedNot reported
Epoetin Alfa-0.924.09Not reportedNot reportedNot reported
Fatigue
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-1.919.84Not reportedNot reportedNot reported
Epoetin Alfa-9.023.77Not reportedNot reportedNot reported
Nausea and Vomiting
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept2.112.34Not reportedNot reportedNot reported
Epoetin Alfa-1.213.11Not reportedNot reportedNot reported
Pain
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-2.125.40Not reportedNot reportedNot reported
Epoetin Alfa-1.721.77Not reportedNot reportedNot reported
Dyspnea
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-1.622.34Not reportedNot reportedNot reported
Epoetin Alfa-8.826.59Not reportedNot reportedNot reported
Insomnia
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-4.026.30Not reportedNot reportedNot reported
Epoetin Alfa-3.033.95Not reportedNot reportedNot reported
Appetite Loss
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-1.123.55Not reportedNot reportedNot reported
Epoetin Alfa-0.025.14Not reportedNot reportedNot reported
Constipation
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-0.821.36Not reportedNot reportedNot reported
Epoetin Alfa0.923.23Not reportedNot reportedNot reported
Diarrhea
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept1.614.58Not reportedNot reportedNot reported
Epoetin Alfa1.218.58Not reportedNot reportedNot reported
Financial difficulties
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-0.819.15Not reportedNot reportedNot reported
Epoetin Alfa-1.522.75Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.70
        value
        1.7
      2. group Id
        OG001
        spread
        20.99
        value
        2.7
    title
    Global Health Status / QoL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.32
        value
        0.1
      2. group Id
        OG001
        spread
        18.30
        value
        4.4
    title
    Physical Functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.59
        value
        -1.9
      2. group Id
        OG001
        spread
        26.92
        value
        -2.6
    title
    Role Functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.17
        value
        2.5
      2. group Id
        OG001
        spread
        18.32
        value
        3.4
    title
    Emotional Functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.79
        value
        2.0
      2. group Id
        OG001
        spread
        20.75
        value
        0.2
    title
    Cognitive Functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.64
        value
        -2.9
      2. group Id
        OG001
        spread
        24.09
        value
        -0.9
    title
    Social Functioning
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.84
        value
        -1.9
      2. group Id
        OG001
        spread
        23.77
        value
        -9.0
    title
    Fatigue
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.34
        value
        2.1
      2. group Id
        OG001
        spread
        13.11
        value
        -1.2
    title
    Nausea and Vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.40
        value
        -2.1
      2. group Id
        OG001
        spread
        21.77
        value
        -1.7
    title
    Pain
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.34
        value
        -1.6
      2. group Id
        OG001
        spread
        26.59
        value
        -8.8
    title
    Dyspnea
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.30
        value
        -4.0
      2. group Id
        OG001
        spread
        33.95
        value
        -3.0
    title
    Insomnia
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.55
        value
        -1.1
      2. group Id
        OG001
        spread
        25.14
        value
        -0.0
    title
    Appetite Loss
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    2. group Id
      OG001
      value
      110
    units
    Participants
description
The EORTC QLQ-C30 is composed of 30 items that includes a global health status score ranging from: 1-7 as well as scores for 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, nausea/vomiting, and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) all ranging from 1-4. Subscale scores are transformed to a 0 to 100 scale. A high score for a functional scale represents a high or healthy level of functioning; a high score for the global health status/health related quality of life (HRQoL) represents a high overall HRQoL; but a high score for a symptom scale represents a high level of symptomatology or problems. Baseline is defined as the last value on or before the first dose of study drug.
dispersion Type
Standard Deviation
groups
  1. description
    Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
    id
    OG000
    title
    Luspatercept
  2. description
    Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
    id
    OG001
    title
    Epoetin Alfa
param Type
MEAN
population Description
All randomized participants who completed the EORTC QLQ-C30 assessment at baseline and post-baseline assessment at the respective visit.
reporting Status
POSTED
time Frame
Baseline and week 24.
title
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30)
type
SECONDARY
unit Of Measure
Score on a scale

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Preserved source evidence · Not medical advice