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NCT01742286 · BASELINE

Baseline characteristics

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) · Source last updated 2020-06-09

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
      5
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      13
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      42
    8. group Id
      BG007
      value
      83
    units
    Participants
groups
  1. description
    Participants in the fasted group who took 300 mg of ceritinib
    id
    BG000
    title
    Fasted: Ceritinib 300 mg/m2
  2. description
    Participants in the fasted group who took 450 mg of ceritinib
    id
    BG001
    title
    Fasted: Ceritinib 450 mg/m2
  3. description
    Participants in the fasted group who took 510 mg of ceritinib
    id
    BG002
    title
    Fasted: Ceritinib 510 mg/m2
  4. description
    Participants in the fasted group who took 560 mg of ceritinib
    id
    BG003
    title
    Fasted: Ceritinib 560 mg/m2
  5. description
    Participants in the fed group who took 320 mg of ceritinib
    id
    BG004
    title
    Fed: Ceritinib 320 mg/m2
  6. description
    Participants in the fed group who took 400 mg of ceritinib
    id
    BG005
    title
    Fed: Ceritinib 400 mg/m2
  7. description
    Participants in the fed group who took 500 mg of ceritinib
    id
    BG006
    title
    Fed: Ceritinib 500 mg/m2
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.27
          value
          11.6
        2. group Id
          BG001
          spread
          4.94
          value
          10.0
        3. group Id
          BG002
          spread
          5.34
          value
          9.2
        4. group Id
          BG003
          spread
          9.90
          value
          9.0
        5. group Id
          BG004
          spread
          4.99
          value
          8.8
        6. group Id
          BG005
          spread
          4.02
          value
          9.2
        7. group Id
          BG006
          spread
          4.73
          value
          7.3
        8. group Id
          BG007
          spread
          4.97
          value
          8.5
    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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          21
        8. group Id
          BG007
          value
          37
      title
      1 - < 7 yrs
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          16
      title
      7 - < 12 yrs
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          30
      title
      12 - < 18 yrs
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          53
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          33
        8. group Id
          BG007
          value
          65
      title
      Caucasian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          11
      title
      Other
    5. categories
      1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
      title
      Native American
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Full analysis set (FAS) included all patients who received at least one dose of ceritinib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      13
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      42
    8. group Id
      BG007
      value
      83
    units
    Participants
groups
  1. description
    Participants in the fasted group who took 300 mg of ceritinib
    id
    BG000
    title
    Fasted: Ceritinib 300 mg/m2
  2. description
    Participants in the fasted group who took 450 mg of ceritinib
    id
    BG001
    title
    Fasted: Ceritinib 450 mg/m2
  3. description
    Participants in the fasted group who took 510 mg of ceritinib
    id
    BG002
    title
    Fasted: Ceritinib 510 mg/m2
  4. description
    Participants in the fasted group who took 560 mg of ceritinib
    id
    BG003
    title
    Fasted: Ceritinib 560 mg/m2
  5. description
    Participants in the fed group who took 320 mg of ceritinib
    id
    BG004
    title
    Fed: Ceritinib 320 mg/m2
  6. description
    Participants in the fed group who took 400 mg of ceritinib
    id
    BG005
    title
    Fed: Ceritinib 400 mg/m2
  7. description
    Participants in the fed group who took 500 mg of ceritinib
    id
    BG006
    title
    Fed: Ceritinib 500 mg/m2
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.27
          value
          11.6
        2. group Id
          BG001
          spread
          4.94
          value
          10.0
        3. group Id
          BG002
          spread
          5.34
          value
          9.2
        4. group Id
          BG003
          spread
          9.90
          value
          9.0
        5. group Id
          BG004
          spread
          4.99
          value
          8.8
        6. group Id
          BG005
          spread
          4.02
          value
          9.2
        7. group Id
          BG006
          spread
          4.73
          value
          7.3
        8. group Id
          BG007
          spread
          4.97
          value
          8.5
    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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          21
        8. group Id
          BG007
          value
          37
      title
      1 - < 7 yrs
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          16
      title
      7 - < 12 yrs
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          30
      title
      12 - < 18 yrs
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          53
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          33
        8. group Id
          BG007
          value
          65
      title
      Caucasian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          11
      title
      Other
    5. categories
      1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
      title
      Native American
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Full analysis set (FAS) included all patients who received at least one dose of ceritinib.

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Preserved source evidence · Not medical advice