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NCT03069352 · BASELINE

Baseline characteristics

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy · Source last updated 2025-09-30

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
      68
    2. group Id
      BG001
      value
      143
    3. group Id
      BG002
      value
      211
    units
    Participants
groups
  1. description
    Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    BG000
    title
    Placebo + Low Dose Cytarabine (LDAC)
  2. description
    Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    BG001
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41.0
          upper Limit
          88.0
          value
          76.0
        2. group Id
          BG001
          lower Limit
          36.0
          upper Limit
          93.0
          value
          76.0
        3. group Id
          BG002
          lower Limit
          36.0
          upper Limit
          93.0
          value
          76.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
        title
        18 to < 65 years
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          69
        title
        65 to < 75 years
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          122
        title
        ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          117
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          149
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          59
        title
        Asian
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          19
        title
        United States
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          82
        title
        European Union
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          15
        title
        China
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
        title
        Japan
      5. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          68
        title
        Rest of World
    description
    Rest of World includes Australia, Brazil, Canada, New Zealand, Puerto Rico, Russia, South Africa, South Korea, and Taiwan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          130
        title
        De novo
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          81
        title
        Secondary
    param Type
    COUNT_OF_PARTICIPANTS
    title
    AML Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      68
    2. group Id
      BG001
      value
      143
    3. group Id
      BG002
      value
      211
    units
    Participants
groups
  1. description
    Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    BG000
    title
    Placebo + Low Dose Cytarabine (LDAC)
  2. description
    Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    BG001
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41.0
          upper Limit
          88.0
          value
          76.0
        2. group Id
          BG001
          lower Limit
          36.0
          upper Limit
          93.0
          value
          76.0
        3. group Id
          BG002
          lower Limit
          36.0
          upper Limit
          93.0
          value
          76.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
        title
        18 to < 65 years
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          69
        title
        65 to < 75 years
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          122
        title
        ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          117
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          149
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          59
        title
        Asian
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          19
        title
        United States
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          82
        title
        European Union
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          15
        title
        China
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
        title
        Japan
      5. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          68
        title
        Rest of World
    description
    Rest of World includes Australia, Brazil, Canada, New Zealand, Puerto Rico, Russia, South Africa, South Korea, and Taiwan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          130
        title
        De novo
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          81
        title
        Secondary
    param Type
    COUNT_OF_PARTICIPANTS
    title
    AML Status
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice