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NCT00949650 · FLOW

Participant flow

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.

groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    FG000
    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
    FG001
    title
    Pemetrexed/Cisplatin Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        188
      2. group Id
        FG001
        num Subjects
        19
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        60
      type
      Completed 6 courses of chemotherapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        17
      type
      Other Adverse Event (AE)
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        11
      type
      Refusal to continue medication
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      type
      Not treated
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Other not specified above
    milestones
    1. achievements
      1. comment
        Treated patients.
        group Id
        FG000
        num Subjects
        230
      2. comment
        Treated patients.
        group Id
        FG001
        num Subjects
        115
      type
      STARTED
    2. achievements
      1. comment
        On treatment at the cut-off date 17MAR2017.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        230
      2. group Id
        FG001
        num Subjects
        115
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison. 345 patients were randomised, 5 patients were not treated: 4 patients were not eligible for treatment and 1 patient in the chemotherapy arm refused to take study medication.
Complete source fields
groups
  1. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    FG000
    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
    FG001
    title
    Pemetrexed/Cisplatin Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        188
      2. group Id
        FG001
        num Subjects
        19
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        60
      type
      Completed 6 courses of chemotherapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        17
      type
      Other Adverse Event (AE)
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        11
      type
      Refusal to continue medication
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      type
      Not treated
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Other not specified above
    milestones
    1. achievements
      1. comment
        Treated patients.
        group Id
        FG000
        num Subjects
        230
      2. comment
        Treated patients.
        group Id
        FG001
        num Subjects
        115
      type
      STARTED
    2. achievements
      1. comment
        On treatment at the cut-off date 17MAR2017.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        230
      2. group Id
        FG001
        num Subjects
        115
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Two-arm, randomised (2:1 ratio), open-label, active-controlled, parallel-group comparison. 345 patients were randomised, 5 patients were not treated: 4 patients were not eligible for treatment and 1 patient in the chemotherapy arm refused to take study medication.

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Preserved source evidence · Not medical advice