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NCT00123474 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      167
    2. group Id
      BG001
      value
      167
    3. group Id
      BG002
      value
      168
    4. group Id
      BG003
      value
      168
    5. group Id
      BG004
      value
      670
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Dasatinib 70 mg BID
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          130
        4. group Id
          BG003
          value
          125
        5. group Id
          BG004
          value
          504
      title
      Less than, equal to (<=) 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          166
      title
      Greater than (>) 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          91
        5. group Id
          BG004
          value
          354
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          77
        5. group Id
          BG004
          value
          316
        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
          75
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          88
        4. group Id
          BG003
          value
          81
        5. group Id
          BG004
          value
          322
      title
      Primary Resistance to Imatinib
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          175
      title
      Acquired Resistance to Imatinib
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          173
      title
      Intolerant to Imatinib
    description
    Primary Resistance: no decrease in white blood cell (WBC) count after ≥ 4 weeks imatinib or not achieved a complete hematologic response (CHR) after 3 months, a major cytogenetic response (MCyR) after 6 months, or a complete cytogenetic response (CCyR) after 12 months. Acquired resistance: achieved MCyR and no longer met the criteria for MCyR. Intolerance: Grade ≥ 3 toxicity considered at least possibly related to imatinib at a dose of ≤ 400 mg/day which led to discontinuation of therapy; tolerated the dose of 400 mg but did not achieve a CCyR and subsequently did not tolerate doses ≥ 600 mg.
    param Type
    NUMBER
    title
    Imatinib Status
    unit Of Measure
    participants
population Description
All participants randomized to a treatment arm are summarized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      167
    2. group Id
      BG001
      value
      167
    3. group Id
      BG002
      value
      168
    4. group Id
      BG003
      value
      168
    5. group Id
      BG004
      value
      670
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Dasatinib 70 mg BID
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          130
        4. group Id
          BG003
          value
          125
        5. group Id
          BG004
          value
          504
      title
      Less than, equal to (<=) 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          166
      title
      Greater than (>) 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          91
        5. group Id
          BG004
          value
          354
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          77
        5. group Id
          BG004
          value
          316
        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
          75
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          88
        4. group Id
          BG003
          value
          81
        5. group Id
          BG004
          value
          322
      title
      Primary Resistance to Imatinib
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          175
      title
      Acquired Resistance to Imatinib
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          173
      title
      Intolerant to Imatinib
    description
    Primary Resistance: no decrease in white blood cell (WBC) count after ≥ 4 weeks imatinib or not achieved a complete hematologic response (CHR) after 3 months, a major cytogenetic response (MCyR) after 6 months, or a complete cytogenetic response (CCyR) after 12 months. Acquired resistance: achieved MCyR and no longer met the criteria for MCyR. Intolerance: Grade ≥ 3 toxicity considered at least possibly related to imatinib at a dose of ≤ 400 mg/day which led to discontinuation of therapy; tolerated the dose of 400 mg but did not achieve a CCyR and subsequently did not tolerate doses ≥ 600 mg.
    param Type
    NUMBER
    title
    Imatinib Status
    unit Of Measure
    participants
population Description
All participants randomized to a treatment arm are summarized.

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Preserved source evidence · Not medical advice