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NCT04266301 · OUTCOME

Key Secondary Endpoint 1: Time to Definitive Deterioration of Fatigue Using Functional Assessment of Cancer Therapy (FACIT)-Fatigue Score

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
up to approx. 52 months

What was measured

FACIT-Fatigue score is a 13-item questionnaire designed to assess fatigue in cancer participants. All items use a 5-point scale ranging from 0 to 4 (0=Not at All to 4=Very Much). The total score ranges from 0 to 52 with higher values representing better quality of life. Time to definitive deterioration of fatigue is defined as time from randomization to at least 3 points worsening from baseline in FACIT-fatigue scores with no subsequently observed improvement above this threshold, or death due to any cause, whichever occurred first.

Analysis population: FAS comprised of all participants 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) + Azacitidine265
Placebo + Azacitidine265

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine13.37Not reported11.9615.90Not reported
Placebo + Azacitidine11.76Not reported10.1513.86Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.750
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.130
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2132
    p Value Comment
    P Value is 1-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.921
    statistical Comment
    log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very High risk MDS, CMML-2) as per IRT
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.750
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.130
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2132
    p Value Comment
    P Value is 1-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.921
    statistical Comment
    log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very High risk MDS, CMML-2) as per IRT
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.96
        upper Limit
        15.90
        value
        13.37
      2. group Id
        OG001
        lower Limit
        10.15
        upper Limit
        13.86
        value
        11.76
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      265
    units
    Participants
description
FACIT-Fatigue score is a 13-item questionnaire designed to assess fatigue in cancer participants. All items use a 5-point scale ranging from 0 to 4 (0=Not at All to 4=Very Much). The total score ranges from 0 to 52 with higher values representing better quality of life. Time to definitive deterioration of fatigue is defined as time from randomization to at least 3 points worsening from baseline in FACIT-fatigue scores with no subsequently observed improvement above this threshold, or death due to any cause, whichever occurred first.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
FAS comprised of all participants to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
up to approx. 52 months
title
Key Secondary Endpoint 1: Time to Definitive Deterioration of Fatigue Using Functional Assessment of Cancer Therapy (FACIT)-Fatigue Score
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice