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NCT04266301 · OUTCOME

Key Secondary Endpoint 2: Red Blood Cell (RBC) Annualized Transfusion Free Rate for Transfusion

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
days per year
Interval / dispersion
Full Range
Time frame
up to approx. 52 months

What was measured

Annualized transfusion free rate is defined as the average number of days in RBC transfusion-free intervals in a year (i.e., the total number of days in RBC transfusion-free intervals divided by the total days in the study multiplied by 365.25), where RBC transfusion-free intervals correspond to cumulative times of intervals with no evidence of RBC transfusion for at least 8 weeks at any point after randomization until death due to any cause.

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 days per year · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine184.3Not reported0365Not reported
Placebo + Azacitidine175.7Not reported0365Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4692
    p Value Comment
    P Value is 1-sided
    statistical Comment
    negative binomial regression model with log link stratified by randomization stratification factor as per IRT and baseline transfusion status
    statistical Method
    negative binomial regression model
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4692
    p Value Comment
    P Value is 1-sided
    statistical Comment
    negative binomial regression model with log link stratified by randomization stratification factor as per IRT and baseline transfusion status
    statistical Method
    negative binomial regression model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        365
        value
        184.3
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        365
        value
        175.7
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      265
    units
    Participants
description
Annualized transfusion free rate is defined as the average number of days in RBC transfusion-free intervals in a year (i.e., the total number of days in RBC transfusion-free intervals divided by the total days in the study multiplied by 365.25), where RBC transfusion-free intervals correspond to cumulative times of intervals with no evidence of RBC transfusion for at least 8 weeks at any point after randomization until death due to any cause.
dispersion Type
Full Range
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 2: Red Blood Cell (RBC) Annualized Transfusion Free Rate for Transfusion
type
SECONDARY
unit Of Measure
days per year

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

Preserved source evidence · Not medical advice