Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00949650 · BASELINE

Baseline characteristics

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation · Source last updated 2018-04-06

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
      230
    2. group Id
      BG001
      value
      115
    3. group Id
      BG002
      value
      345
    units
    Participants
groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    BG000
    title
    Afatinib 40 mg
  2. description
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    id
    BG001
    title
    Pemetrexed/Cisplatin Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.1
          value
          60.5
        2. group Id
          BG001
          spread
          10.0
          value
          59.9
        3. group Id
          BG002
          spread
          10.1
          value
          60.3
    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
          147
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          224
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          121
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          166
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          249
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          96
      title
      Non-Asian
    description
    Race (Asian/non-Asian) was a stratification factor.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          138
      title
      EGFR mutation category: L858R
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          169
      title
      EGFR mutation category: Deletion Exon 19
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          38
      title
      EGFR mutation category: Other
    description
    EGFR mutation group (L858R/Deletion Exon 19/Other) was a stratification factor.
    param Type
    NUMBER
    title
    Epidermal Growth Factor Receptor (EGFR) mutation group
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          133
      title
      ECOG PS 0 (baseline)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          211
      title
      ECOG PS 1 (baseline)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      ECOG PS 2 (baseline)
    description
    ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. 2. Ambulatory (\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. 3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
population Description
Randomised Set (RS): The randomised set includes all patients who were randomised to receive treatment, whether treated or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      230
    2. group Id
      BG001
      value
      115
    3. group Id
      BG002
      value
      345
    units
    Participants
groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    BG000
    title
    Afatinib 40 mg
  2. description
    Patients received Pemetrexed 500 mg/m\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
    id
    BG001
    title
    Pemetrexed/Cisplatin Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.1
          value
          60.5
        2. group Id
          BG001
          spread
          10.0
          value
          59.9
        3. group Id
          BG002
          spread
          10.1
          value
          60.3
    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
          147
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          224
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          121
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          166
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          249
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          96
      title
      Non-Asian
    description
    Race (Asian/non-Asian) was a stratification factor.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          138
      title
      EGFR mutation category: L858R
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          169
      title
      EGFR mutation category: Deletion Exon 19
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          38
      title
      EGFR mutation category: Other
    description
    EGFR mutation group (L858R/Deletion Exon 19/Other) was a stratification factor.
    param Type
    NUMBER
    title
    Epidermal Growth Factor Receptor (EGFR) mutation group
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          133
      title
      ECOG PS 0 (baseline)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          211
      title
      ECOG PS 1 (baseline)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      ECOG PS 2 (baseline)
    description
    ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. 2. Ambulatory (\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. 3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
population Description
Randomised Set (RS): The randomised set includes all patients who were randomised to receive treatment, whether treated or not.

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

Preserved source evidence · Not medical advice