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NCT01077544 · BASELINE

Baseline characteristics

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-12-29

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
      8
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      15
    units
    Participants
groups
  1. description
    1 year to \< 10 years pediatric patients
    id
    BG000
    title
    Group 1
  2. description
    \>= 10 years to \<18 years pediatric patients
    id
    BG001
    title
    Group 2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.16
          value
          6.8
        2. group Id
          BG001
          spread
          2.81
          value
          13.7
        3. group Id
          BG002
          spread
          4.12
          value
          10.0
    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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.739
          value
          24.60
        2. group Id
          BG001
          spread
          17.533
          value
          48.89
        3. group Id
          BG002
          spread
          17.328
          value
          35.93
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.49
          value
          119.9
        2. group Id
          BG001
          spread
          16.32
          value
          158.0
        3. group Id
          BG002
          spread
          23.02
          value
          137.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.7654
          value
          16.962
        2. group Id
          BG001
          spread
          3.4563
          value
          18.944
        3. group Id
          BG002
          spread
          2.7795
          value
          17.887
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
population Description
Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      8
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      15
    units
    Participants
groups
  1. description
    1 year to \< 10 years pediatric patients
    id
    BG000
    title
    Group 1
  2. description
    \>= 10 years to \<18 years pediatric patients
    id
    BG001
    title
    Group 2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.16
          value
          6.8
        2. group Id
          BG001
          spread
          2.81
          value
          13.7
        3. group Id
          BG002
          spread
          4.12
          value
          10.0
    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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.739
          value
          24.60
        2. group Id
          BG001
          spread
          17.533
          value
          48.89
        3. group Id
          BG002
          spread
          17.328
          value
          35.93
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.49
          value
          119.9
        2. group Id
          BG001
          spread
          16.32
          value
          158.0
        3. group Id
          BG002
          spread
          23.02
          value
          137.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.7654
          value
          16.962
        2. group Id
          BG001
          spread
          3.4563
          value
          18.944
        3. group Id
          BG002
          spread
          2.7795
          value
          17.887
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
population Description
Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.

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Preserved source evidence · Not medical advice