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NCT00481247 · BASELINE

Baseline characteristics

A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia · Source last updated 2017-02-15

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
      259
    2. group Id
      BG001
      value
      260
    3. group Id
      BG002
      value
      519
    units
    Participants
groups
  1. description
    Tablets, oral, dasatinib 100 mg once daily (QD)
    id
    BG000
    title
    Dasatinib
  2. description
    Tablets, oral, imatinib 400 mg once daily (QD)
    id
    BG001
    title
    Imatinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          46.4
        2. group Id
          BG001
          spread
          13.9
          value
          47.1
        3. group Id
          BG002
          spread
          14.2
          value
          46.7
    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
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
      title
      <20 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          225
      title
      Between 21 and 45 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          236
      title
      Between 46 and 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          33
      title
      Between 66 and 75 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          212
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          144
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          307
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          275
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          203
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          418
      title
      ECOG score=0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          99
      title
      ECOG score=1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      ECOG score=2
    description
    ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          55
    param Type
    NUMBER
    title
    Number of Patients With Liver Involvement
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          154
    param Type
    NUMBER
    title
    Number of Participants With Spleen Involvement
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      259
    2. group Id
      BG001
      value
      260
    3. group Id
      BG002
      value
      519
    units
    Participants
groups
  1. description
    Tablets, oral, dasatinib 100 mg once daily (QD)
    id
    BG000
    title
    Dasatinib
  2. description
    Tablets, oral, imatinib 400 mg once daily (QD)
    id
    BG001
    title
    Imatinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          46.4
        2. group Id
          BG001
          spread
          13.9
          value
          47.1
        3. group Id
          BG002
          spread
          14.2
          value
          46.7
    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
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
      title
      <20 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          225
      title
      Between 21 and 45 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          236
      title
      Between 46 and 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          33
      title
      Between 66 and 75 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          212
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          144
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          307
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          275
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          203
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          418
      title
      ECOG score=0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          99
      title
      ECOG score=1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      ECOG score=2
    description
    ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          55
    param Type
    NUMBER
    title
    Number of Patients With Liver Involvement
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          154
    param Type
    NUMBER
    title
    Number of Participants With Spleen Involvement
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice