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NCT02467270 · BASELINE

Baseline characteristics

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses · Source last updated 2026-03-17

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
      94
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      94
    4. group Id
      BG003
      value
      282
    units
    Participants
groups
  1. description
    Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    BG000
    title
    Treatment Period: Cohort A: Ponatinib 45 mg
  2. description
    Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    BG001
    title
    Treatment Period: Cohort B: Ponatinib 30 mg
  3. description
    Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
    id
    BG002
    title
    Treatment Period: Cohort C: Ponatinib 15 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.77
          value
          47.7
        2. group Id
          BG001
          spread
          12.90
          value
          48.5
        3. group Id
          BG002
          spread
          12.71
          value
          48.8
        4. group Id
          BG003
          spread
          13.45
          value
          48.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    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
          44
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          141
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          68
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          209
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          43
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          222
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          38
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Austria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Chile
    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
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Denmark
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      United Kingdom
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Hong Kong
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Italy
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Japan
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Poland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          107
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Russia
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Singapore
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.841
          value
          78.14
        2. group Id
          BG001
          spread
          18.375
          value
          77.56
        3. group Id
          BG002
          spread
          17.434
          value
          76.71
        4. group Id
          BG003
          spread
          18.879
          value
          77.47
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.104
          value
          1.68
        2. group Id
          BG001
          spread
          0.098
          value
          1.68
        3. group Id
          BG002
          spread
          0.090
          value
          1.68
        4. group Id
          BG003
          spread
          0.097
          value
          1.68
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          92
        4. group Id
          BG003
          value
          277
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height at Baseline.
    title
    Height
    unit Of Measure
    meter
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          219
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Score= 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          61
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Score= 1
    3. 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
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Score= 2
    description
    ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity). Only categories with data are reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          155
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      <60/No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      <60/Yes
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          21
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      >=60/No
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          49
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      >=60/Yes
    description
    Randomization stratum is based on Age (years)/History of Hypertension, Diabetes, or Hyperlipidemia. The number in the reported categories denotes age and Yes or No indicates history of hypertension, diabetes or hyperlipidemia was present or absent. '\<' indicates less than and '\>=' indicates greater than equal to in the reported categories.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratum
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.41
          value
          7.4
        2. group Id
          BG001
          spread
          6.32
          value
          7.6
        3. group Id
          BG002
          spread
          5.36
          value
          7.1
        4. group Id
          BG003
          spread
          5.7
          value
          7.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          280
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for analysis.
    title
    Time Since Diagnosis
    unit Of Measure
    years
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          255
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Imatinib
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          212
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Dasatinib
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          73
        4. group Id
          BG003
          value
          219
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Nilotinib
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          54
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Bosutinib
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Radotinib
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Tyrosine Kinase Inhibitor (TKIs)
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          122
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          124
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          30
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      4
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Approved TKIs
    unit Of Measure
    Participants
population Description
Safety Population included all participants who received at least one dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      94
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      94
    4. group Id
      BG003
      value
      282
    units
    Participants
groups
  1. description
    Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    BG000
    title
    Treatment Period: Cohort A: Ponatinib 45 mg
  2. description
    Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    BG001
    title
    Treatment Period: Cohort B: Ponatinib 30 mg
  3. description
    Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
    id
    BG002
    title
    Treatment Period: Cohort C: Ponatinib 15 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.77
          value
          47.7
        2. group Id
          BG001
          spread
          12.90
          value
          48.5
        3. group Id
          BG002
          spread
          12.71
          value
          48.8
        4. group Id
          BG003
          spread
          13.45
          value
          48.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    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
          44
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          141
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          68
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          209
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          43
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          222
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          38
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Austria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Chile
    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
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Denmark
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      United Kingdom
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Hong Kong
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Italy
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Japan
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Poland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          107
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Russia
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Singapore
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.841
          value
          78.14
        2. group Id
          BG001
          spread
          18.375
          value
          77.56
        3. group Id
          BG002
          spread
          17.434
          value
          76.71
        4. group Id
          BG003
          spread
          18.879
          value
          77.47
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.104
          value
          1.68
        2. group Id
          BG001
          spread
          0.098
          value
          1.68
        3. group Id
          BG002
          spread
          0.090
          value
          1.68
        4. group Id
          BG003
          spread
          0.097
          value
          1.68
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          92
        4. group Id
          BG003
          value
          277
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height at Baseline.
    title
    Height
    unit Of Measure
    meter
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          219
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Score= 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          61
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Score= 1
    3. 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
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Score= 2
    description
    ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity). Only categories with data are reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          155
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      <60/No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      <60/Yes
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          21
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      >=60/No
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          49
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      >=60/Yes
    description
    Randomization stratum is based on Age (years)/History of Hypertension, Diabetes, or Hyperlipidemia. The number in the reported categories denotes age and Yes or No indicates history of hypertension, diabetes or hyperlipidemia was present or absent. '\<' indicates less than and '\>=' indicates greater than equal to in the reported categories.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratum
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.41
          value
          7.4
        2. group Id
          BG001
          spread
          6.32
          value
          7.6
        3. group Id
          BG002
          spread
          5.36
          value
          7.1
        4. group Id
          BG003
          spread
          5.7
          value
          7.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          280
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for analysis.
    title
    Time Since Diagnosis
    unit Of Measure
    years
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          255
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Imatinib
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          212
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Dasatinib
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          73
        4. group Id
          BG003
          value
          219
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Nilotinib
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          54
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Bosutinib
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      Radotinib
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Tyrosine Kinase Inhibitor (TKIs)
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          122
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          124
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          30
      denoms
      1. counts
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          282
        units
        Participants
      title
      4
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Approved TKIs
    unit Of Measure
    Participants
population Description
Safety Population included all participants who received at least one dose of study drug.

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