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NCT02993523 · BASELINE

Baseline characteristics

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy · Source last updated 2026-06-11

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
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      145
    4. group Id
      BG003
      value
      286
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      443
    units
    Participants
groups
  1. description
    Participants enrolled under original protocol received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG000
    title
    Group 1: Placebo + Azacitidine 75 mg/m^2
  2. description
    Participants enrolled under original protocol received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG001
    title
    Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
  3. description
    Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG002
    title
    Group 2: Placebo + Azacitidine 75 mg/m^2
  4. description
    Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG003
    title
    Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
  5. description
    Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG004
    title
    Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          Standard deviation (SD) was not estimable for 1 participant.
          group Id
          BG000
          spread
          NA
          value
          61.0
        2. comment
          SD was not estimable for 1 participant.
          group Id
          BG001
          spread
          NA
          value
          65.0
        3. group Id
          BG002
          spread
          5.70
          value
          75.1
        4. group Id
          BG003
          spread
          6.08
          value
          75.6
        5. group Id
          BG004
          spread
          7.44
          value
          70.2
        6. group Id
          BG005
          spread
          6.08
          value
          75.2
    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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          114
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          177
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          87
        4. group Id
          BG003
          value
          172
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          266
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          66
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          109
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          109
        4. group Id
          BG003
          value
          217
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          327
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full Analysis Set included all Group 1 and 2 participants randomized by Interactive Voice Response System (IVRS)/Interactive Web Response System (IWRS) (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      145
    4. group Id
      BG003
      value
      286
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      443
    units
    Participants
groups
  1. description
    Participants enrolled under original protocol received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG000
    title
    Group 1: Placebo + Azacitidine 75 mg/m^2
  2. description
    Participants enrolled under original protocol received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG001
    title
    Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
  3. description
    Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG002
    title
    Group 2: Placebo + Azacitidine 75 mg/m^2
  4. description
    Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG003
    title
    Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
  5. description
    Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    BG004
    title
    Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          Standard deviation (SD) was not estimable for 1 participant.
          group Id
          BG000
          spread
          NA
          value
          61.0
        2. comment
          SD was not estimable for 1 participant.
          group Id
          BG001
          spread
          NA
          value
          65.0
        3. group Id
          BG002
          spread
          5.70
          value
          75.1
        4. group Id
          BG003
          spread
          6.08
          value
          75.6
        5. group Id
          BG004
          spread
          7.44
          value
          70.2
        6. group Id
          BG005
          spread
          6.08
          value
          75.2
    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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          114
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          177
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          87
        4. group Id
          BG003
          value
          172
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          266
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          66
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          109
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          109
        4. group Id
          BG003
          value
          217
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          327
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full Analysis Set included all Group 1 and 2 participants randomized by Interactive Voice Response System (IVRS)/Interactive Web Response System (IWRS) (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax.

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

Preserved source evidence · Not medical advice