Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02993523 · FLOW

Participant flow

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.

groups
  1. description
    Participants enrolled under original protocol received venetoclax-matching placebo, orally, once daily (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, subcutaneously (SC) or intravenously (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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    title
    Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrew Consent
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        138
      4. group Id
        FG003
        num Subjects
        222
      5. group Id
        FG004
        num Subjects
        6
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        145
      4. group Id
        FG003
        num Subjects
        286
      5. group Id
        FG004
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        48
      5. group Id
        FG004
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        144
      4. group Id
        FG003
        num Subjects
        238
      5. group Id
        FG004
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Total of 443 participants were enrolled. 433 participants were randomized in Group 1 and Group 2 to receive placebo or venetoclax 100/200/400mg+azacitidine 75mg/m\^2. 10 participants in open-label China cohort received venetoclax 400 mg + azacitidine 75 mg/m\^2 up to data cut-off date: 01 December 2021. This study is ongoing.
recruitment Details
Participants were randomized in Group 1 per original protocol stratified by age (18 - \< 75, ≥ 75), and region (US, EU, Japan (JP), Rest of world (ROW)) and Group 2 during or after Amendment 1 stratified by age (18 - \< 75, ≥ 75), cytogenetic risk (intermediate, poor) and region (US, EU, China, JP, ROW).
Complete source fields
groups
  1. description
    Participants enrolled under original protocol received venetoclax-matching placebo, orally, once daily (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, subcutaneously (SC) or intravenously (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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    title
    Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrew Consent
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        138
      4. group Id
        FG003
        num Subjects
        222
      5. group Id
        FG004
        num Subjects
        6
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Reason not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        145
      4. group Id
        FG003
        num Subjects
        286
      5. group Id
        FG004
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        48
      5. group Id
        FG004
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        144
      4. group Id
        FG003
        num Subjects
        238
      5. group Id
        FG004
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Total of 443 participants were enrolled. 433 participants were randomized in Group 1 and Group 2 to receive placebo or venetoclax 100/200/400mg+azacitidine 75mg/m\^2. 10 participants in open-label China cohort received venetoclax 400 mg + azacitidine 75 mg/m\^2 up to data cut-off date: 01 December 2021. This study is ongoing.
recruitment Details
Participants were randomized in Group 1 per original protocol stratified by age (18 - \< 75, ≥ 75), and region (US, EU, Japan (JP), Rest of world (ROW)) and Group 2 during or after Amendment 1 stratified by age (18 - \< 75, ≥ 75), cytogenetic risk (intermediate, poor) and region (US, EU, China, JP, ROW).

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

Preserved source evidence · Not medical advice