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NCT00123474 · FLOW

Participant flow

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML · Source last updated 2016-08-25

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

groups
  1. description
    Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
    id
    FG000
    title
    Dasatinib 100 mg QD
  2. description
    Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
    id
    FG001
    title
    Dasatinib 140 mg QD
  3. description
    Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    FG002
    title
    Dasatinib 50 mg BID
  4. description
    Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    FG003
    title
    Dasatinib 70 mg BID
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Randomized, never treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        168
      4. group Id
        FG003
        num Subjects
        168
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        166
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        166
      4. group Id
        FG003
        num Subjects
        167
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Randomized to Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      not reported when site closed
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        29
      4. group Id
        FG003
        num Subjects
        27
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        5
      type
      Investigator Request
    5. reasons
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        57
      4. group Id
        FG003
        num Subjects
        60
      type
      non-specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        51
      type
      Study Drug Toxicity
    7. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        16
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        Randomized to 50 mg BID but received 100 mg QD.
        group Id
        FG000
        num Subjects
        165
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        167
      4. group Id
        FG003
        num Subjects
        167
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        Randomized to 100 mg QD but received 50 mg BID.
        group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        165
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        167
      4. group Id
        FG003
        num Subjects
        167
      type
      NOT COMPLETED
    title
    As Treated at Study Closure
pre Assignment Details
724 participants were enrolled, 670 were randomized, and 662 were treated with study drug. Reasons for non-randomization: 38 no longer met criteria, 8 other reasons, 7 withdrew consent, and 1 death.
recruitment Details
Study initiated July 2005 and completed July 2014.
Complete source fields
groups
  1. description
    Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
    id
    FG000
    title
    Dasatinib 100 mg QD
  2. description
    Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
    id
    FG001
    title
    Dasatinib 140 mg QD
  3. description
    Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    FG002
    title
    Dasatinib 50 mg BID
  4. description
    Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    FG003
    title
    Dasatinib 70 mg BID
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Randomized, never treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        168
      4. group Id
        FG003
        num Subjects
        168
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        166
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        166
      4. group Id
        FG003
        num Subjects
        167
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Randomized to Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      not reported when site closed
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        29
      4. group Id
        FG003
        num Subjects
        27
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        5
      type
      Investigator Request
    5. reasons
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        57
      4. group Id
        FG003
        num Subjects
        60
      type
      non-specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        51
      type
      Study Drug Toxicity
    7. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        16
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        Randomized to 50 mg BID but received 100 mg QD.
        group Id
        FG000
        num Subjects
        165
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        167
      4. group Id
        FG003
        num Subjects
        167
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        Randomized to 100 mg QD but received 50 mg BID.
        group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        165
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        167
      4. group Id
        FG003
        num Subjects
        167
      type
      NOT COMPLETED
    title
    As Treated at Study Closure
pre Assignment Details
724 participants were enrolled, 670 were randomized, and 662 were treated with study drug. Reasons for non-randomization: 38 no longer met criteria, 8 other reasons, 7 withdrew consent, and 1 death.
recruitment Details
Study initiated July 2005 and completed July 2014.

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Preserved source evidence · Not medical advice