Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01074047 · FLOW

Participant flow

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) · Source last updated 2017-08-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    FG000
    title
    Azacitidine (AZA)
  2. description
    CCRs included: * 1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed * 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC * 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
    id
    FG001
    title
    Conventional Care Regimens (CCR)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        66
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        21
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        48
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        58
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        39
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        241
      2. group Id
        FG001
        num Subjects
        247
      type
      STARTED
    2. achievements
      1. comment
        5 patients not treated with any drug regimen
        group Id
        FG000
        num Subjects
        236
      2. comment
        7 patients not treated with any drug regimen
        group Id
        FG001
        num Subjects
        240
      type
      Treated Population
    3. achievements
      1. comment
        Received at least one dose of study medication and had at least 1 post dose safety assessment
        group Id
        FG000
        num Subjects
        236
      2. comment
        Received at least one dose of study medication and had at least 1 post dose safety assessment
        group Id
        FG001
        num Subjects
        235
      type
      Safety Population
    4. achievements
      1. comment
        Did not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment
        group Id
        FG000
        num Subjects
        179
      2. comment
        Did not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment
        group Id
        FG001
        num Subjects
        191
      type
      Evaluable Population
    5. achievements
      1. comment
        Participants who were continuing study treatment at the time of study closure
        group Id
        FG000
        num Subjects
        24
      2. comment
        Participants who were continuing study treatment at the time of study closure
        group Id
        FG001
        num Subjects
        13
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        234
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        116
      2. group Id
        FG001
        num Subjects
        124
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Alive at study closure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        140
      2. group Id
        FG001
        num Subjects
        163
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        136
      type
      NOT COMPLETED
    title
    Survival Follow-Up Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. comment
        2 participants did not enroll in the extension period.
        group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. comment
        Participants who enrolled in the extension phase
        group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        0
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Extension Phase
recruitment Details
This was a multicenter, international Phase 3 study conducted at 107 investigational sites in 18 countries including South Korea, China, Taiwan, Australia, Canada, United States, Poland, Russia, Czech Republic, Israel, France, Italy, Spain, Germany, United Kingdom, Belgium, Austria and the Netherlands.
Complete source fields
groups
  1. description
    Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    FG000
    title
    Azacitidine (AZA)
  2. description
    CCRs included: * 1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed * 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC * 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
    id
    FG001
    title
    Conventional Care Regimens (CCR)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        89
      2. group Id
        FG001
        num Subjects
        66
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        21
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        48
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        58
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        39
      type
      Miscellaneous
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        241
      2. group Id
        FG001
        num Subjects
        247
      type
      STARTED
    2. achievements
      1. comment
        5 patients not treated with any drug regimen
        group Id
        FG000
        num Subjects
        236
      2. comment
        7 patients not treated with any drug regimen
        group Id
        FG001
        num Subjects
        240
      type
      Treated Population
    3. achievements
      1. comment
        Received at least one dose of study medication and had at least 1 post dose safety assessment
        group Id
        FG000
        num Subjects
        236
      2. comment
        Received at least one dose of study medication and had at least 1 post dose safety assessment
        group Id
        FG001
        num Subjects
        235
      type
      Safety Population
    4. achievements
      1. comment
        Did not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment
        group Id
        FG000
        num Subjects
        179
      2. comment
        Did not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment
        group Id
        FG001
        num Subjects
        191
      type
      Evaluable Population
    5. achievements
      1. comment
        Participants who were continuing study treatment at the time of study closure
        group Id
        FG000
        num Subjects
        24
      2. comment
        Participants who were continuing study treatment at the time of study closure
        group Id
        FG001
        num Subjects
        13
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        234
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        116
      2. group Id
        FG001
        num Subjects
        124
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Alive at study closure
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        140
      2. group Id
        FG001
        num Subjects
        163
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        136
      type
      NOT COMPLETED
    title
    Survival Follow-Up Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. comment
        2 participants did not enroll in the extension period.
        group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. comment
        Participants who enrolled in the extension phase
        group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        0
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Extension Phase
recruitment Details
This was a multicenter, international Phase 3 study conducted at 107 investigational sites in 18 countries including South Korea, China, Taiwan, Australia, Canada, United States, Poland, Russia, Czech Republic, Israel, France, Italy, Spain, Germany, United Kingdom, Belgium, Austria and the Netherlands.

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

Preserved source evidence · Not medical advice