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NCT03268954 · OUTCOME

Change From Baseline in Health-Related Quality of Life (HRQOL) Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2025-10-29

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, at approximately 58 months

What was measured

The 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. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The change from baseline at end of treatment is reported.

Analysis population: ITT Population included all participants who were randomized. All participants with PRO measurements at baseline and with data available at end of treatment were analyzed for this outcome measure.

Groups in this outcome

Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

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

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210

Reported measurements

Global Health Status/QoL Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^260.322.11Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^261.621.13Not reportedNot reportedNot reported
Global Health Status/QoL Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2124
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-3.025.93Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-8.426.89Not reportedNot reportedNot reported
Physical Functioning Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^269.422.63Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^275.720.38Not reportedNot reportedNot reported
Physical Functioning Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-7.522.82Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-13.427.51Not reportedNot reportedNot reported
Role Functioning Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^266.930.88Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^273.728.55Not reportedNot reportedNot reported
Role Functioning Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2126
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-11.835.41Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-18.336.72Not reportedNot reportedNot reported
Emotional Functioning Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^276.020.96Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^277.622.10Not reportedNot reportedNot reported
Emotional Functioning Score: Change from Baselline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2124
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-2.523.80Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-5.922.41Not reportedNot reportedNot reported
Cognitive Functioning Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^284.618.29Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^286.117.60Not reportedNot reportedNot reported
Cognitive Functioning Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-7.222.65Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-10.424.38Not reportedNot reportedNot reported
Social Functioning Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2208
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^279.325.37Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^278.825.82Not reportedNot reportedNot reported
Social Functioning Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2122
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-13.733.89Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-16.534.78Not reportedNot reportedNot reported
Fatigue Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^238.525.44Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^233.824.24Not reportedNot reportedNot reported
Fatigue Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2126
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^26.626.41Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^212.331.22Not reportedNot reportedNot reported
Nausea/Vomiting Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^24.611.39Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^24.710.96Not reportedNot reportedNot reported
Nausea/Vomiting Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^22.419.08Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^21.915.00Not reportedNot reportedNot reported
Pain Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^220.925.55Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^219.426.42Not reportedNot reportedNot reported
Pain Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^25.830.36Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^26.833.34Not reportedNot reportedNot reported
Dyspnoea Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^225.429.83Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^224.428.90Not reportedNot reportedNot reported
Dyspnoea Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2124
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^25.928.95Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^25.929.46Not reportedNot reportedNot reported
Insomnia Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^227.227.96Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^225.730.68Not reportedNot reportedNot reported
Insomnia Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2145
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2124
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^23.234.32Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^24.634.09Not reportedNot reportedNot reported
Appetite Loss Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^223.429.29Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^215.623.99Not reportedNot reportedNot reported
Appetite Loss Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^24.638.68Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^216.034.03Not reportedNot reportedNot reported
Constipation Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^214.724.78Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^213.822.47Not reportedNot reportedNot reported
Constipation Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2125
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^25.529.56Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^25.128.42Not reportedNot reportedNot reported
Diarrhoea Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2210
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^27.618.84Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^27.016.75Not reportedNot reportedNot reported
Diarrhoea Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2124
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^23.022.80Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^21.927.65Not reportedNot reportedNot reported
Financial Difficulties Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2208
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^214.225.37Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^218.426.76Not reportedNot reportedNot reported
Financial Difficulties Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2146
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2122
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^25.927.03Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^27.430.46Not reportedNot reportedNot reported
QLQ-C30 Summary Score: Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2211
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2208
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^277.914.90Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^280.515.08Not reportedNot reportedNot reported
QLQ-C30 Summary Score: Change from Baseline

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2145
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2120
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^2-6.118.84Not reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2-8.617.75Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.11
        value
        60.3
      2. group Id
        OG001
        spread
        21.13
        value
        61.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    Global Health Status/QoL Score: Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.93
        value
        -3.0
      2. group Id
        OG001
        spread
        26.89
        value
        -8.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        124
      units
      Participants
    title
    Global Health Status/QoL Score: Change from Baseline
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.63
        value
        69.4
      2. group Id
        OG001
        spread
        20.38
        value
        75.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    Physical Functioning Score: Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.82
        value
        -7.5
      2. group Id
        OG001
        spread
        27.51
        value
        -13.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        125
      units
      Participants
    title
    Physical Functioning Score: Change from Baseline
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.88
        value
        66.9
      2. group Id
        OG001
        spread
        28.55
        value
        73.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    Role Functioning Score: Baseline
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.41
        value
        -11.8
      2. group Id
        OG001
        spread
        36.72
        value
        -18.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    Role Functioning Score: Change from Baseline
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.96
        value
        76.0
      2. group Id
        OG001
        spread
        22.10
        value
        77.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    Emotional Functioning Score: Baseline
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.80
        value
        -2.5
      2. group Id
        OG001
        spread
        22.41
        value
        -5.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        124
      units
      Participants
    title
    Emotional Functioning Score: Change from Baselline
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.29
        value
        84.6
      2. group Id
        OG001
        spread
        17.60
        value
        86.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    Cognitive Functioning Score: Baseline
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.65
        value
        -7.2
      2. group Id
        OG001
        spread
        24.38
        value
        -10.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        125
      units
      Participants
    title
    Cognitive Functioning Score: Change from Baseline
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.37
        value
        79.3
      2. group Id
        OG001
        spread
        25.82
        value
        78.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        208
      units
      Participants
    title
    Social Functioning Score: Baseline
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.89
        value
        -13.7
      2. group Id
        OG001
        spread
        34.78
        value
        -16.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Social Functioning Score: Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      211
    2. group Id
      OG001
      value
      210
    units
    Participants
description
The 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. Most of the 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The change from baseline at end of treatment is reported.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    OG000
    title
    Azacitidine 75 mg/m^2
  2. description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    OG001
    title
    Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
param Type
MEAN
population Description
ITT Population included all participants who were randomized. All participants with PRO measurements at baseline and with data available at end of treatment were analyzed for this outcome measure.
reporting Status
POSTED
time Frame
Baseline, at approximately 58 months
title
Change From Baseline in Health-Related Quality of Life (HRQOL) Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice