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NCT00556322 · FLOW

Participant flow

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2015-02-23

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

groups
  1. description
    Participants received either pemetrexed 500 milligrams per square meter (mg/m\^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
    id
    FG000
    title
    Comparator
  2. description
    Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
    id
    FG001
    title
    Erlotinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        158
      2. group Id
        FG001
        num Subjects
        168
      type
      Insufficient therapeutic response
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Ongoing at data cutoff
    8. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        14
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        221
      2. group Id
        FG001
        num Subjects
        203
      type
      STARTED
    2. achievements
      1. comment
        Data cutoff was 01 August 2010
        group Id
        FG000
        num Subjects
        0
      2. comment
        Data cutoff was 01 August 2010
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        221
      2. group Id
        FG001
        num Subjects
        203
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received either pemetrexed 500 milligrams per square meter (mg/m\^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
    id
    FG000
    title
    Comparator
  2. description
    Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
    id
    FG001
    title
    Erlotinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        158
      2. group Id
        FG001
        num Subjects
        168
      type
      Insufficient therapeutic response
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Ongoing at data cutoff
    8. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        14
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        221
      2. group Id
        FG001
        num Subjects
        203
      type
      STARTED
    2. achievements
      1. comment
        Data cutoff was 01 August 2010
        group Id
        FG000
        num Subjects
        0
      2. comment
        Data cutoff was 01 August 2010
        group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        221
      2. group Id
        FG001
        num Subjects
        203
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice