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NCT05309668 · BASELINE

Baseline characteristics

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN · Source last updated 2026-08-13

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
      15
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      36
    units
    Participants
groups
  1. description
    Global Cohort 1 (\>=4 to \<7 years)
    id
    BG000
    title
    Global Cohort 1
  2. description
    Global Cohort 2 (\>=1 to \<4 years)
    id
    BG001
    title
    Global Cohort 2
  3. description
    Japan Cohort (\>=1 to \<7 years)
    id
    BG002
    title
    Japan Cohort
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.101
          value
          5.08
        2. group Id
          BG001
          spread
          0.819
          value
          2.49
        3. group Id
          BG002
          spread
          2.300
          value
          4.43
        4. group Id
          BG003
          spread
          1.681
          value
          3.78
    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
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          22
        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
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          32
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          22
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        title
        Germany
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        title
        Italy
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        title
        Japan
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Russian Federation (the)
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Spain
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        United States of America (the)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Country
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1073
          value
          0.771
        2. group Id
          BG001
          spread
          0.0603
          value
          0.558
        3. group Id
          BG002
          spread
          0.1234
          value
          0.605
        4. group Id
          BG003
          spread
          0.1349
          value
          0.652
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BSA
    unit Of Measure
    m2
  7. classes
    1. 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
        title
        >=0.40 to <0.50
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          11
        title
        >=0.50 to <0.60
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        title
        >=0.60 to <0.70
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          10
        title
        >=0.70 to <0.90
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        >=0.90 to <1.10
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        >=1.10 to <=1.29
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Body surface area group (m2)
    unit Of Measure
    Participants
population Description
Baseline analysis was based on all patients in the who received selumetinib (safety analysis set).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      36
    units
    Participants
groups
  1. description
    Global Cohort 1 (\>=4 to \<7 years)
    id
    BG000
    title
    Global Cohort 1
  2. description
    Global Cohort 2 (\>=1 to \<4 years)
    id
    BG001
    title
    Global Cohort 2
  3. description
    Japan Cohort (\>=1 to \<7 years)
    id
    BG002
    title
    Japan Cohort
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.101
          value
          5.08
        2. group Id
          BG001
          spread
          0.819
          value
          2.49
        3. group Id
          BG002
          spread
          2.300
          value
          4.43
        4. group Id
          BG003
          spread
          1.681
          value
          3.78
    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
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          22
        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
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          32
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          22
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        title
        Germany
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        title
        Italy
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        title
        Japan
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Russian Federation (the)
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Spain
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        United States of America (the)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Country
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1073
          value
          0.771
        2. group Id
          BG001
          spread
          0.0603
          value
          0.558
        3. group Id
          BG002
          spread
          0.1234
          value
          0.605
        4. group Id
          BG003
          spread
          0.1349
          value
          0.652
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BSA
    unit Of Measure
    m2
  7. classes
    1. 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
        title
        >=0.40 to <0.50
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          11
        title
        >=0.50 to <0.60
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        title
        >=0.60 to <0.70
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          10
        title
        >=0.70 to <0.90
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        >=0.90 to <1.10
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        >=1.10 to <=1.29
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Body surface area group (m2)
    unit Of Measure
    Participants
population Description
Baseline analysis was based on all patients in the who received selumetinib (safety analysis set).

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Preserved source evidence · Not medical advice