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NCT01844765 · BASELINE

Baseline characteristics

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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
      33
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    BG000
    title
    Resistant/Intolerant Ph+ CML in CP
  2. description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
    id
    BG001
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      1 to < 12 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      12 to < 18 years
    param Type
    NUMBER
    population Description
    Full Analysis Set (FAS): All patients who received at least one dose of study medication.
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          34
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Full Analysis Set (FAS): All patients who received at least one dose of study medication.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          30
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          23
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    NUMBER
    population Description
    Full Analysis Set (FAS): All patients who received at least one dose of study medication.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS): All patients who received at least one dose of study medication.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    BG000
    title
    Resistant/Intolerant Ph+ CML in CP
  2. description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis
    id
    BG001
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      1 to < 12 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      12 to < 18 years
    param Type
    NUMBER
    population Description
    Full Analysis Set (FAS): All patients who received at least one dose of study medication.
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          34
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Full Analysis Set (FAS): All patients who received at least one dose of study medication.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          30
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          23
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    NUMBER
    population Description
    Full Analysis Set (FAS): All patients who received at least one dose of study medication.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS): All patients who received at least one dose of study medication.

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Preserved source evidence · Not medical advice