Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04266301 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      265
    2. group Id
      BG001
      value
      265
    3. group Id
      BG002
      value
      530
    units
    Participants
groups
  1. description
    Participants were randomized to sabatolimab plus Azacitidine
    id
    BG000
    title
    Sabatolimab (MBG453) + Azacitidine
  2. description
    Participants were randomized to placebo plus Azacitidine
    id
    BG001
    title
    Placebo + Azacitidine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.46
          value
          70.2
        2. group Id
          BG001
          spread
          11.23
          value
          69.1
        3. group Id
          BG002
          spread
          11.35
          value
          69.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          183
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          186
        3. group Id
          BG002
          value
          347
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          284
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          235
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          193
      title
      ECOG performance status: 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          302
      title
      ECOG performance status: 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          35
      title
      ECOG performance status: 2
    description
    Eastern Cooperative Oncology Group (ECOG) performance status scale is a widely used standard of care criteria used to assess the functional status of a patient with cancer to measure how the disease impacts the patient's daily living abilities. This scale has a range from 0 - 5. The higher the grade, the worse the patient's abilities: 0 implies fully active, able to carry on all pre-disease performance without restriction and 5 implies death.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG performance status
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) comprised of all participants to whom study treatment had been assigned by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      265
    2. group Id
      BG001
      value
      265
    3. group Id
      BG002
      value
      530
    units
    Participants
groups
  1. description
    Participants were randomized to sabatolimab plus Azacitidine
    id
    BG000
    title
    Sabatolimab (MBG453) + Azacitidine
  2. description
    Participants were randomized to placebo plus Azacitidine
    id
    BG001
    title
    Placebo + Azacitidine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.46
          value
          70.2
        2. group Id
          BG001
          spread
          11.23
          value
          69.1
        3. group Id
          BG002
          spread
          11.35
          value
          69.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          183
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          186
        3. group Id
          BG002
          value
          347
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          284
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          235
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          193
      title
      ECOG performance status: 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          302
      title
      ECOG performance status: 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          35
      title
      ECOG performance status: 2
    description
    Eastern Cooperative Oncology Group (ECOG) performance status scale is a widely used standard of care criteria used to assess the functional status of a patient with cancer to measure how the disease impacts the patient's daily living abilities. This scale has a range from 0 - 5. The higher the grade, the worse the patient's abilities: 0 implies fully active, able to carry on all pre-disease performance without restriction and 5 implies death.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG performance status
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) comprised of all participants to whom study treatment had been assigned by randomization.

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

Preserved source evidence · Not medical advice