Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03173248 · BASELINE

Baseline characteristics

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation · Source last updated 2026-06-29

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
      72
    2. group Id
      BG001
      value
      74
    3. group Id
      BG002
      value
      146
    units
    Participants
groups
  1. description
    Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
    id
    BG000
    title
    AG-120 + Azacitidine
  2. description
    Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
    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
          6.18
          value
          74.5
        2. group Id
          BG001
          spread
          7.39
          value
          75.2
        3. group Id
          BG002
          spread
          6.81
          value
          74.8
    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
          30
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          66
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          80
        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
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          53
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          86
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          34
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          84
        title
        Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
FAS included all participants who were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      72
    2. group Id
      BG001
      value
      74
    3. group Id
      BG002
      value
      146
    units
    Participants
groups
  1. description
    Participants received AG-120 500 mg orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
    id
    BG000
    title
    AG-120 + Azacitidine
  2. description
    Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
    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
          6.18
          value
          74.5
        2. group Id
          BG001
          spread
          7.39
          value
          75.2
        3. group Id
          BG002
          spread
          6.81
          value
          74.8
    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
          30
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          66
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          80
        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
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          53
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          86
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          34
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          84
        title
        Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
FAS included all participants who were randomized.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice