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NCT02569242 · FLOW

Participant flow

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer · Source last updated 2022-07-06

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

groups
  1. description
    Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    FG000
    title
    Nivolumab Arm
  2. description
    Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    FG001
    title
    Active Comparator Arm (Docetaxel/Paclitaxel)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        Included in intention-to-treat analysis for overall survival and progression-free survival
        group Id
        FG000
        num Subjects
        210
      2. comment
        Included in intention-to-treat analysis for overall survival and progression-free survival
        group Id
        FG001
        num Subjects
        209
      comment
      Enrolled and randomly assigned
      type
      STARTED
    2. achievements
      1. comment
        Analysed for safety
        group Id
        FG000
        num Subjects
        209
      2. comment
        Analysed for safety
        group Id
        FG001
        num Subjects
        208
      comment
      Received assigned treatment of IMP
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    FG000
    title
    Nivolumab Arm
  2. description
    Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    FG001
    title
    Active Comparator Arm (Docetaxel/Paclitaxel)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        Included in intention-to-treat analysis for overall survival and progression-free survival
        group Id
        FG000
        num Subjects
        210
      2. comment
        Included in intention-to-treat analysis for overall survival and progression-free survival
        group Id
        FG001
        num Subjects
        209
      comment
      Enrolled and randomly assigned
      type
      STARTED
    2. achievements
      1. comment
        Analysed for safety
        group Id
        FG000
        num Subjects
        209
      2. comment
        Analysed for safety
        group Id
        FG001
        num Subjects
        208
      comment
      Received assigned treatment of IMP
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice