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NCT02559687 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180) · Source last updated 2022-09-14

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), every 3 weeks (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    FG000
    title
    Pembrolizumab 200 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        112
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Sponsor Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        121
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        121
      type
      Received First Course of Pembrolizumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        121
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 185 participants screened for inclusion, 121 were enrolled and received treatment. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    FG000
    title
    Pembrolizumab 200 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        112
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Sponsor Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        121
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        121
      type
      Received First Course of Pembrolizumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        121
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 185 participants screened for inclusion, 121 were enrolled and received treatment. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.

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Preserved source evidence · Not medical advice