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NCT04266301 · OUTCOME

Number of Participants Who Become Red Blood Cells (RBC) Transfusion Independent After Randomization

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to approx. 52 months

What was measured

Improvement in RBC transfusion independence as per International Working Group for MDS (IWG-MDS) criteria. RBC transfusion independence was defined as having received 0 units of RBC transfusions during at least 8 consecutive weeks after randomization. The number of participants was shown in only those with transfusion dependence at baseline (BL).

Analysis population: Participants of the full analysis set (FAS) who were RBC transfusion dependent at baseline.

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) + Azacitidine96
Placebo + Azacitidine108

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine50Not reportedNot reportedNot reportedNot reported
Placebo + Azacitidine53Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        53
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      108
    units
    Participants
description
Improvement in RBC transfusion independence as per International Working Group for MDS (IWG-MDS) criteria. RBC transfusion independence was defined as having received 0 units of RBC transfusions during at least 8 consecutive weeks after randomization. The number of participants was shown in only those with transfusion dependence at baseline (BL).
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
COUNT_OF_PARTICIPANTS
population Description
Participants of the full analysis set (FAS) who were RBC transfusion dependent at baseline.
reporting Status
POSTED
time Frame
up to approx. 52 months
title
Number of Participants Who Become Red Blood Cells (RBC) Transfusion Independent After Randomization
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice