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NCT02564263 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181) · Source last updated 2023-03-13

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

groups
  1. description
    Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
    id
    FG001
    title
    Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        29
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        262
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        19
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        4
      type
      Sponsor's decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        314
      2. group Id
        FG001
        num Subjects
        314
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        314
      2. group Id
        FG001
        num Subjects
        296
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        314
      2. group Id
        FG001
        num Subjects
        314
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
At the time of the primary analysis data cut-off of 15-Oct-2018, 67 participants were ongoing in the study.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
    id
    FG001
    title
    Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        29
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        262
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        19
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        4
      type
      Sponsor's decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        314
      2. group Id
        FG001
        num Subjects
        314
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        314
      2. group Id
        FG001
        num Subjects
        296
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        314
      2. group Id
        FG001
        num Subjects
        314
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
At the time of the primary analysis data cut-off of 15-Oct-2018, 67 participants were ongoing in the study.

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