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NCT00525148 · FLOW

Participant flow

LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations · Source last updated 2016-09-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG000
    title
    First-line Afatinib 40 mg
  2. description
    First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG001
    title
    First-line Afatinib 50 mg
  3. description
    Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG002
    title
    Second-line Afatinib 40 mg
  4. description
    Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG003
    title
    Second-line Afatinib 50 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      type
      Other Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        49
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Refused continuation of study medication
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Other than stated
    milestones
    1. achievements
      1. comment
        entered and treated
        group Id
        FG000
        num Subjects
        23
      2. comment
        entered and treated
        group Id
        FG001
        num Subjects
        38
      3. comment
        entered and treated
        group Id
        FG002
        num Subjects
        7
      4. comment
        entered and treated
        group Id
        FG003
        num Subjects
        61
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        61
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG000
    title
    First-line Afatinib 40 mg
  2. description
    First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG001
    title
    First-line Afatinib 50 mg
  3. description
    Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG002
    title
    Second-line Afatinib 40 mg
  4. description
    Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
    id
    FG003
    title
    Second-line Afatinib 50 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      type
      Other Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        49
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Refused continuation of study medication
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Other than stated
    milestones
    1. achievements
      1. comment
        entered and treated
        group Id
        FG000
        num Subjects
        23
      2. comment
        entered and treated
        group Id
        FG001
        num Subjects
        38
      3. comment
        entered and treated
        group Id
        FG002
        num Subjects
        7
      4. comment
        entered and treated
        group Id
        FG003
        num Subjects
        61
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        61
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice