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NCT04266301 · OUTCOME

Change From Baseline of Global Health Status/Quality of Life Scores Using European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQ-C30).

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Up to Cycle 12 Day 1 (C12D1) (1 cycle = 28 days)

What was measured

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer participants. Participant's responses to 2 questions (Items 29+30: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. Change from baseline to Cycle 12 Day 1 as presented.

Analysis population: FAS population with non-missing baseline (Cycle 1 Day 1) and Cycle 12 Day 1 EORTC-QLQ-C30 assessments. FAS comprised of all patients to whom study treatment had been assigned by randomization.

Groups in this outcome

Sabatolimab (MBG453) + Azacitidine

Participants were randomized to sabatolimab plus Azacitidine

Placebo + Azacitidine

Participants were randomized to placebo plus Azacitidine

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

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453) + Azacitidine64
Placebo + Azacitidine62

Reported measurements

Source class 1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine8.7223.071Not reportedNot reportedNot reported
Placebo + Azacitidine8.2019.932Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.071
        value
        8.72
      2. group Id
        OG001
        spread
        19.932
        value
        8.20
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    2. group Id
      OG001
      value
      62
    units
    Participants
description
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer participants. Participant's responses to 2 questions (Items 29+30: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. Change from baseline to Cycle 12 Day 1 as presented.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were randomized to sabatolimab plus Azacitidine
    id
    OG000
    title
    Sabatolimab (MBG453) + Azacitidine
  2. description
    Participants were randomized to placebo plus Azacitidine
    id
    OG001
    title
    Placebo + Azacitidine
param Type
MEAN
population Description
FAS population with non-missing baseline (Cycle 1 Day 1) and Cycle 12 Day 1 EORTC-QLQ-C30 assessments. FAS comprised of all patients to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
Up to Cycle 12 Day 1 (C12D1) (1 cycle = 28 days)
title
Change From Baseline of Global Health Status/Quality of Life Scores Using European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQ-C30).
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice