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NCT01283516 · BASELINE

Baseline characteristics

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase · Source last updated 2019-03-15

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
      2
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      14
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      255
    10. group Id
      BG009
      value
      304
    units
    Participants
groups
  1. description
    Participants receiving 50 mg of LDK378
    id
    BG000
    title
    LDK378 50 mg
  2. description
    Participants receiving 100 mg of LDK378
    id
    BG001
    title
    LDK378 100 mg
  3. description
    Participants receiving 200 mg of LDK378
    id
    BG002
    title
    LDK378 200 mg
  4. description
    Participants receiving 300 mg of LDK378
    id
    BG003
    title
    LDK378 300 mg
  5. description
    Participants receiving 400 mg of LDK378
    id
    BG004
    title
    LDK378 400 mg
  6. description
    Participants receiving 500 mg of LDK378
    id
    BG005
    title
    LDK378 500 mg
  7. description
    Participants receiving 600 mg of LDK378
    id
    BG006
    title
    LDK378 600 mg
  8. description
    Participants receiving 700 mg of LDK378
    id
    BG007
    title
    LDK378 700 mg
  9. description
    Participants receiving 750 mg of LDK378.
    id
    BG008
    title
    LDK378 750 mg
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          23.33
          value
          46.5
        2. group Id
          BG001
          spread
          12.02
          value
          30.5
        3. group Id
          BG002
          spread
          10.69
          value
          53.7
        4. group Id
          BG003
          spread
          5.03
          value
          58.7
        5. group Id
          BG004
          spread
          15.62
          value
          48.7
        6. group Id
          BG005
          spread
          15.99
          value
          55.0
        7. group Id
          BG006
          spread
          13.22
          value
          54.6
        8. group Id
          BG007
          spread
          4.67
          value
          56.4
        9. group Id
          BG008
          spread
          12.08
          value
          51.9
        10. group Id
          BG009
          spread
          12.41
          value
          52.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
    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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          215
        10. group Id
          BG009
          value
          255
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          40
        10. group Id
          BG009
          value
          49
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          136
        10. group Id
          BG009
          value
          170
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          119
        10. group Id
          BG009
          value
          134
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
    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
          0
        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
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          26
        10. group Id
          BG009
          value
          32
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Hispanic or Latino
    2. 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
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          17
        10. group Id
          BG009
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Chinese
    3. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Indian (Indian subcontinent)
    4. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Mixed Ethnicity
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          205
        10. group Id
          BG009
          value
          244
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          160
        10. group Id
          BG009
          value
          199
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Caucasian
    2. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Black
    3. 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
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          87
        10. group Id
          BG009
          value
          95
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Asian
    4. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Pacific Islander
    6. 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
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Other
    param Type
    NUMBER
    title
    Predominant Race
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.80
          value
          60.8
        2. group Id
          BG001
          spread
          5.94
          value
          67.8
        3. group Id
          BG002
          spread
          17.20
          value
          69.2
        4. group Id
          BG003
          spread
          9.70
          value
          54.1
        5. group Id
          BG004
          spread
          15.91
          value
          69.2
        6. group Id
          BG005
          spread
          18.74
          value
          72.2
        7. group Id
          BG006
          spread
          13.23
          value
          63.8
        8. group Id
          BG007
          spread
          16.05
          value
          61.6
        9. group Id
          BG008
          spread
          15.64
          value
          69.2
        10. group Id
          BG009
          spread
          15.61
          value
          68.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.07
          value
          169.0
        2. group Id
          BG001
          spread
          14.14
          value
          178.0
        3. group Id
          BG002
          spread
          3.04
          value
          161.3
        4. group Id
          BG003
          spread
          5.82
          value
          164.6
        5. group Id
          BG004
          spread
          9.35
          value
          169.9
        6. group Id
          BG005
          spread
          12.24
          value
          166.4
        7. group Id
          BG006
          spread
          8.67
          value
          165.1
        8. group Id
          BG007
          spread
          5.05
          value
          163.6
        9. group Id
          BG008
          spread
          9.87
          value
          167.5
        10. group Id
          BG009
          spread
          9.78
          value
          167.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          254
        10. group Id
          BG009
          value
          302
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Height was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.
    title
    Height
    unit Of Measure
    centimenters (cm)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.16
          value
          21.1
        2. group Id
          BG001
          spread
          5.30
          value
          21.8
        3. group Id
          BG002
          spread
          5.69
          value
          26.5
        4. group Id
          BG003
          spread
          5.08
          value
          20.2
        5. group Id
          BG004
          spread
          5.38
          value
          24.0
        6. group Id
          BG005
          spread
          5.41
          value
          25.9
        7. group Id
          BG006
          spread
          2.78
          value
          23.1
        8. group Id
          BG007
          spread
          6.06
          value
          24.3
        9. group Id
          BG008
          spread
          4.40
          value
          24.5
        10. group Id
          BG009
          spread
          4.48
          value
          24.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          254
        10. group Id
          BG009
          value
          302
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Body Mass Index was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          65
        10. group Id
          BG009
          value
          76
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      0:Fully active,in line with pre-disease activities
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          161
        10. group Id
          BG009
          value
          193
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      1: Able to carry out light work
    3. 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
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          28
        10. group Id
          BG009
          value
          34
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      2:Capable of self-care up & about >50% of the time
    4. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      3: Limited self-care, confined to bed/chair >50%
    description
    The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
    param Type
    NUMBER
    title
    WHO/ECOG Performance status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          159
        10. group Id
          BG009
          value
          192
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Never Smoked
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          88
        10. group Id
          BG009
          value
          104
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Ex-Smoker
    3. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Current Smoker
    param Type
    NUMBER
    title
    Smoking History
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Patients were classified according to the intended treatment dose group.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      14
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      5
    9. group Id
      BG008
      value
      255
    10. group Id
      BG009
      value
      304
    units
    Participants
groups
  1. description
    Participants receiving 50 mg of LDK378
    id
    BG000
    title
    LDK378 50 mg
  2. description
    Participants receiving 100 mg of LDK378
    id
    BG001
    title
    LDK378 100 mg
  3. description
    Participants receiving 200 mg of LDK378
    id
    BG002
    title
    LDK378 200 mg
  4. description
    Participants receiving 300 mg of LDK378
    id
    BG003
    title
    LDK378 300 mg
  5. description
    Participants receiving 400 mg of LDK378
    id
    BG004
    title
    LDK378 400 mg
  6. description
    Participants receiving 500 mg of LDK378
    id
    BG005
    title
    LDK378 500 mg
  7. description
    Participants receiving 600 mg of LDK378
    id
    BG006
    title
    LDK378 600 mg
  8. description
    Participants receiving 700 mg of LDK378
    id
    BG007
    title
    LDK378 700 mg
  9. description
    Participants receiving 750 mg of LDK378.
    id
    BG008
    title
    LDK378 750 mg
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          23.33
          value
          46.5
        2. group Id
          BG001
          spread
          12.02
          value
          30.5
        3. group Id
          BG002
          spread
          10.69
          value
          53.7
        4. group Id
          BG003
          spread
          5.03
          value
          58.7
        5. group Id
          BG004
          spread
          15.62
          value
          48.7
        6. group Id
          BG005
          spread
          15.99
          value
          55.0
        7. group Id
          BG006
          spread
          13.22
          value
          54.6
        8. group Id
          BG007
          spread
          4.67
          value
          56.4
        9. group Id
          BG008
          spread
          12.08
          value
          51.9
        10. group Id
          BG009
          spread
          12.41
          value
          52.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
    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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          215
        10. group Id
          BG009
          value
          255
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          40
        10. group Id
          BG009
          value
          49
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          136
        10. group Id
          BG009
          value
          170
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          119
        10. group Id
          BG009
          value
          134
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
    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
          0
        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
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          26
        10. group Id
          BG009
          value
          32
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Hispanic or Latino
    2. 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
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          17
        10. group Id
          BG009
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Chinese
    3. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Indian (Indian subcontinent)
    4. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Mixed Ethnicity
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          205
        10. group Id
          BG009
          value
          244
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          160
        10. group Id
          BG009
          value
          199
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Caucasian
    2. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Black
    3. 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
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          87
        10. group Id
          BG009
          value
          95
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Asian
    4. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Pacific Islander
    6. 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
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Other
    param Type
    NUMBER
    title
    Predominant Race
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.80
          value
          60.8
        2. group Id
          BG001
          spread
          5.94
          value
          67.8
        3. group Id
          BG002
          spread
          17.20
          value
          69.2
        4. group Id
          BG003
          spread
          9.70
          value
          54.1
        5. group Id
          BG004
          spread
          15.91
          value
          69.2
        6. group Id
          BG005
          spread
          18.74
          value
          72.2
        7. group Id
          BG006
          spread
          13.23
          value
          63.8
        8. group Id
          BG007
          spread
          16.05
          value
          61.6
        9. group Id
          BG008
          spread
          15.64
          value
          69.2
        10. group Id
          BG009
          spread
          15.61
          value
          68.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.07
          value
          169.0
        2. group Id
          BG001
          spread
          14.14
          value
          178.0
        3. group Id
          BG002
          spread
          3.04
          value
          161.3
        4. group Id
          BG003
          spread
          5.82
          value
          164.6
        5. group Id
          BG004
          spread
          9.35
          value
          169.9
        6. group Id
          BG005
          spread
          12.24
          value
          166.4
        7. group Id
          BG006
          spread
          8.67
          value
          165.1
        8. group Id
          BG007
          spread
          5.05
          value
          163.6
        9. group Id
          BG008
          spread
          9.87
          value
          167.5
        10. group Id
          BG009
          spread
          9.78
          value
          167.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          254
        10. group Id
          BG009
          value
          302
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Height was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.
    title
    Height
    unit Of Measure
    centimenters (cm)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.16
          value
          21.1
        2. group Id
          BG001
          spread
          5.30
          value
          21.8
        3. group Id
          BG002
          spread
          5.69
          value
          26.5
        4. group Id
          BG003
          spread
          5.08
          value
          20.2
        5. group Id
          BG004
          spread
          5.38
          value
          24.0
        6. group Id
          BG005
          spread
          5.41
          value
          25.9
        7. group Id
          BG006
          spread
          2.78
          value
          23.1
        8. group Id
          BG007
          spread
          6.06
          value
          24.3
        9. group Id
          BG008
          spread
          4.40
          value
          24.5
        10. group Id
          BG009
          spread
          4.48
          value
          24.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          254
        10. group Id
          BG009
          value
          302
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Body Mass Index was not collected for 1 patient each in the 700 mg arm and the 750 mg arm.
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          65
        10. group Id
          BG009
          value
          76
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      0:Fully active,in line with pre-disease activities
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          161
        10. group Id
          BG009
          value
          193
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      1: Able to carry out light work
    3. 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
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          28
        10. group Id
          BG009
          value
          34
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      2:Capable of self-care up & about >50% of the time
    4. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      3: Limited self-care, confined to bed/chair >50%
    description
    The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
    param Type
    NUMBER
    title
    WHO/ECOG Performance status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          159
        10. group Id
          BG009
          value
          192
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Never Smoked
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          88
        10. group Id
          BG009
          value
          104
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Ex-Smoker
    3. 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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          255
        10. group Id
          BG009
          value
          304
        units
        Participants
      title
      Current Smoker
    param Type
    NUMBER
    title
    Smoking History
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least one dose of LDK378. Patients were classified according to the intended treatment dose group.

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