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NCT00982111 · FLOW

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First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin · Source last updated 2022-01-11

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

groups
  1. description
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle. Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles. Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
    id
    FG000
    title
    Necitumumab + Pemetrexed + Cisplatin
  2. description
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles. Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
    id
    FG001
    title
    Pemetrexed + Cisplatin
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        39
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        6
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      type
      New Anti-Cancer Therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Medical Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        19
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Global Study End
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Sponsor's Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        315
      2. group Id
        FG001
        num Subjects
        318
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        304
      2. group Id
        FG001
        num Subjects
        312
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        236
      2. group Id
        FG001
        num Subjects
        246
      type
      Death Due to Any Cause
    4. achievements
      1. group Id
        FG000
        num Subjects
        236
      2. group Id
        FG001
        num Subjects
        246
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        72
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
Complete source fields
groups
  1. description
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle. Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles. Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
    id
    FG000
    title
    Necitumumab + Pemetrexed + Cisplatin
  2. description
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles. Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.
    id
    FG001
    title
    Pemetrexed + Cisplatin
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        39
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        6
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      type
      New Anti-Cancer Therapy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Medical Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        19
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Global Study End
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Sponsor's Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        315
      2. group Id
        FG001
        num Subjects
        318
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        304
      2. group Id
        FG001
        num Subjects
        312
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        236
      2. group Id
        FG001
        num Subjects
        246
      type
      Death Due to Any Cause
    4. achievements
      1. group Id
        FG000
        num Subjects
        236
      2. group Id
        FG001
        num Subjects
        246
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        72
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.

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Preserved source evidence · Not medical advice