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NCT04266301 · OUTCOME

All Collected Deaths

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
from randomization until end of trial, up to approx. 52 months

What was measured

Deaths were collected from randomization until the end of the trial, approx. 52 months, including post-treatment survival follow up period.

Analysis population: Clinical database population: All randomized participants: participants who died before treatment, during treatment and post-treatment.

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

Pre-treatment deaths

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453) + Azacitidine265
Placebo + Azacitidine265
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine0Not reportedNot reportedNot reportedNot reported
Placebo + Azacitidine1Not reportedNot reportedNot reportedNot reported
On-treatment deaths

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453) + Azacitidine265
Placebo + Azacitidine265
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine18Not reportedNot reportedNot reportedNot reported
Placebo + Azacitidine37Not reportedNot reportedNot reportedNot reported
Post-treatment deaths

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453) + Azacitidine247
Placebo + Azacitidine228
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine143Not reportedNot reportedNot reportedNot reported
Placebo + Azacitidine122Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453) + Azacitidine265
Placebo + Azacitidine265
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine161Not reportedNot reportedNot reportedNot reported
Placebo + Azacitidine160Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        265
      units
      Participants
    title
    Pre-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        37
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        265
      units
      Participants
    title
    On-treatment deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        122
    denoms
    1. counts
      1. group Id
        OG000
        value
        247
      2. group Id
        OG001
        value
        228
      units
      Participants
    title
    Post-treatment deaths
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        160
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        265
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      265
    units
    Participants
description
Deaths were collected from randomization until the end of the trial, approx. 52 months, including post-treatment survival follow up period.
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
NUMBER
population Description
Clinical database population: All randomized participants: participants who died before treatment, during treatment and post-treatment.
reporting Status
POSTED
time Frame
from randomization until end of trial, up to approx. 52 months
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice