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NCT00777036 · BASELINE

Baseline characteristics

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib · Source last updated 2025-08-29

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
      29
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      84
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      133
    units
    Participants
groups
  1. description
    Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    BG000
    title
    Cohort 1
  2. description
    Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    BG001
    title
    Cohort 2
  3. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    BG002
    title
    Cohort 3
  4. description
    Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
    id
    BG003
    title
    PK Sub-Study
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.774
          value
          12.60
        2. group Id
          BG001
          spread
          3.680
          value
          12.10
        3. group Id
          BG002
          spread
          4.418
          value
          11.95
        4. group Id
          BG003
          spread
          1.154
          value
          13.33
        5. group Id
          BG004
          spread
          4.255
          value
          12.05
    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
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
      title
      < 2 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
      title
      >= 2 to < 7 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          40
      title
      >= 7 to < 12 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          73
      title
      >= 12 to < 18 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      >= 18 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          66
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          67
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          25
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          101
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          91
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          32
      title
      Asian
    4. 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
          1
      title
      American Indian or Alaska Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      29
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      84
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      133
    units
    Participants
groups
  1. description
    Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    id
    BG000
    title
    Cohort 1
  2. description
    Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    id
    BG001
    title
    Cohort 2
  3. description
    Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    id
    BG002
    title
    Cohort 3
  4. description
    Children and adolescents received powder for oral suspension (PFOS) at a dose of 90 mg/m2 QD to evaluate the pharmacokinetics of dasatinib.
    id
    BG003
    title
    PK Sub-Study
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.774
          value
          12.60
        2. group Id
          BG001
          spread
          3.680
          value
          12.10
        3. group Id
          BG002
          spread
          4.418
          value
          11.95
        4. group Id
          BG003
          spread
          1.154
          value
          13.33
        5. group Id
          BG004
          spread
          4.255
          value
          12.05
    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
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
      title
      < 2 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
      title
      >= 2 to < 7 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          40
      title
      >= 7 to < 12 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          73
      title
      >= 12 to < 18 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      >= 18 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          66
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          67
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          25
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          101
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          91
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          32
      title
      Asian
    4. 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
          1
      title
      American Indian or Alaska Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice