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NCT01523587 · BASELINE

Baseline characteristics

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy · Source last updated 2019-02-15

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
      398
    2. group Id
      BG001
      value
      397
    3. group Id
      BG002
      value
      795
    units
    Participants
groups
  1. description
    Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
    id
    BG000
    title
    Afatinib
  2. description
    Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
    id
    BG001
    title
    Erlotinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.39
          value
          64.9
        2. group Id
          BG001
          spread
          8.98
          value
          63.4
        3. group Id
          BG002
          spread
          8.72
          value
          64.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Randomised set
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          129
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          335
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          666
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Randomised set
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          191
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          291
        3. group Id
          BG002
          value
          579
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
    description
    Ethnicity was not captured in this trial.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Randomised set
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      398
    2. group Id
      BG001
      value
      397
    3. group Id
      BG002
      value
      795
    units
    Participants
groups
  1. description
    Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
    id
    BG000
    title
    Afatinib
  2. description
    Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
    id
    BG001
    title
    Erlotinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.39
          value
          64.9
        2. group Id
          BG001
          spread
          8.98
          value
          63.4
        3. group Id
          BG002
          spread
          8.72
          value
          64.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Randomised set
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          129
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          335
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          666
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Randomised set
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          191
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          291
        3. group Id
          BG002
          value
          579
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
    description
    Ethnicity was not captured in this trial.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Randomised set
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice