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NCT01121393 · BASELINE

Baseline characteristics

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Source last updated 2018-12-14

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
      242
    2. group Id
      BG001
      value
      122
    3. group Id
      BG002
      value
      364
    units
    Participants
groups
  1. description
    Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
    id
    BG000
    title
    Afatinib 40 Milligram (mg)
  2. description
    Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
    id
    BG001
    title
    Gemcitabine / 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
          11.2
          value
          56.7
        2. group Id
          BG001
          spread
          10.1
          value
          55.6
        3. group Id
          BG002
          spread
          10.9
          value
          56.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Treated Set
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          238
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          126
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          138
        title
        L858R (L858R alone and L858R + Deletion Exon 19)
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          186
        title
        Deletion Exon 19 (alone)
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          40
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    description
    EGFR mutation group (L858R / Deletion Exon 19 / other) was a stratification factor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Epidermal growth factor receptor (EGFR)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          89
        title
        ECOG PS 0 (baseline)
      2. measurements
        1. group Id
          BG000
          value
          194
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          275
        title
        ECOG PS 1 (baseline)
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    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 selfcare, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) performance status (PS)
    unit Of Measure
    Participants
population Description
The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      242
    2. group Id
      BG001
      value
      122
    3. group Id
      BG002
      value
      364
    units
    Participants
groups
  1. description
    Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
    id
    BG000
    title
    Afatinib 40 Milligram (mg)
  2. description
    Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
    id
    BG001
    title
    Gemcitabine / 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
          11.2
          value
          56.7
        2. group Id
          BG001
          spread
          10.1
          value
          55.6
        3. group Id
          BG002
          spread
          10.9
          value
          56.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Treated Set
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          238
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          126
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          138
        title
        L858R (L858R alone and L858R + Deletion Exon 19)
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          186
        title
        Deletion Exon 19 (alone)
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          40
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    description
    EGFR mutation group (L858R / Deletion Exon 19 / other) was a stratification factor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Epidermal growth factor receptor (EGFR)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          89
        title
        ECOG PS 0 (baseline)
      2. measurements
        1. group Id
          BG000
          value
          194
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          275
        title
        ECOG PS 1 (baseline)
      denoms
      1. counts
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          364
        units
        Participants
    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 selfcare, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) performance status (PS)
    unit Of Measure
    Participants
population Description
The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.

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Preserved source evidence · Not medical advice