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NCT01647711 · BASELINE

Baseline characteristics

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations · Source last updated 2017-01-31

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
      6
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      11
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      35
    units
    Participants
groups
  1. description
    Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG000
    title
    Afatinib 90mg
  2. description
    Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG001
    title
    Afatinib 120mg
  3. description
    Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG002
    title
    Afatinib 150mg
  4. description
    Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG003
    title
    Afatinib 160mg
  5. description
    Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG004
    title
    Afatinib 200mg
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          64
          upper Limit
          80
          value
          65.0
        2. group Id
          BG001
          lower Limit
          50
          upper Limit
          77
          value
          58.0
        3. group Id
          BG002
          lower Limit
          54
          upper Limit
          77
          value
          65.0
        4. group Id
          BG003
          lower Limit
          45
          upper Limit
          70
          value
          61.0
        5. group Id
          BG004
          lower Limit
          54
          upper Limit
          75
          value
          62.5
        6. group Id
          BG005
          lower Limit
          45
          upper Limit
          80
          value
          64.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
population Description
Treated set which included all patients who took at least one dose of afatinib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      11
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      35
    units
    Participants
groups
  1. description
    Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG000
    title
    Afatinib 90mg
  2. description
    Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG001
    title
    Afatinib 120mg
  3. description
    Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG002
    title
    Afatinib 150mg
  4. description
    Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG003
    title
    Afatinib 160mg
  5. description
    Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    BG004
    title
    Afatinib 200mg
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          64
          upper Limit
          80
          value
          65.0
        2. group Id
          BG001
          lower Limit
          50
          upper Limit
          77
          value
          58.0
        3. group Id
          BG002
          lower Limit
          54
          upper Limit
          77
          value
          65.0
        4. group Id
          BG003
          lower Limit
          45
          upper Limit
          70
          value
          61.0
        5. group Id
          BG004
          lower Limit
          54
          upper Limit
          75
          value
          62.5
        6. group Id
          BG005
          lower Limit
          45
          upper Limit
          80
          value
          64.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
population Description
Treated set which included all patients who took at least one dose of afatinib.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice