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NCT02564263 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      314
    2. group Id
      BG001
      value
      314
    3. group Id
      BG002
      value
      628
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
    id
    BG000
    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
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          62.6
        2. group Id
          BG001
          spread
          9.6
          value
          62.0
        3. group Id
          BG002
          spread
          9.5
          value
          62.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          84
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          273
        2. group Id
          BG001
          value
          271
        3. group Id
          BG002
          value
          544
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          44
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          561
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          23
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          248
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          351
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          226
        title
        PD-L1 CPS ≥10
      2. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          194
        3. group Id
          BG002
          value
          393
        title
        PD-L1 CPS <10
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Not Evaluable
    description
    Participants were assessed for their PD-L1 tumor expression levels by immunohistochemistry assay on tumor tissue from a newly obtained biopsy. PD-L1 CPS was calculated as the number of PD-L1 positive cells (tumor cells, macrophages, lymphocytes) divided by the total tumor cells and is expressed as a percentage. Participants were classified based on their PD-L1 tumor status as being either PD-L1 CPS ≥10 or PD-L1 CPS \<10.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          243
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          385
        title
        RoW
    description
    Participants were classified based on their geographic region of enrollment as either being from Asia or from outside of Asia (Rest of World \[RoW\]).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          403
        title
        Squamous cell carcinoma
      2. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          225
        title
        Adenocarcinoma of esophagus & EGJ Siewert type I
    description
    Participants were classified based on their tumor histology (cell type) as either having squamous cell carcinoma or having adenocarcinoma of esophagus and esophagogastric junction (EGJ) Siewert type I.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      314
    2. group Id
      BG001
      value
      314
    3. group Id
      BG002
      value
      628
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
    id
    BG000
    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
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          62.6
        2. group Id
          BG001
          spread
          9.6
          value
          62.0
        3. group Id
          BG002
          spread
          9.5
          value
          62.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          84
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          273
        2. group Id
          BG001
          value
          271
        3. group Id
          BG002
          value
          544
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          44
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          561
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          23
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          248
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          351
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          226
        title
        PD-L1 CPS ≥10
      2. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          194
        3. group Id
          BG002
          value
          393
        title
        PD-L1 CPS <10
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Not Evaluable
    description
    Participants were assessed for their PD-L1 tumor expression levels by immunohistochemistry assay on tumor tissue from a newly obtained biopsy. PD-L1 CPS was calculated as the number of PD-L1 positive cells (tumor cells, macrophages, lymphocytes) divided by the total tumor cells and is expressed as a percentage. Participants were classified based on their PD-L1 tumor status as being either PD-L1 CPS ≥10 or PD-L1 CPS \<10.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          243
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          385
        title
        RoW
    description
    Participants were classified based on their geographic region of enrollment as either being from Asia or from outside of Asia (Rest of World \[RoW\]).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          403
        title
        Squamous cell carcinoma
      2. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          225
        title
        Adenocarcinoma of esophagus & EGJ Siewert type I
    description
    Participants were classified based on their tumor histology (cell type) as either having squamous cell carcinoma or having adenocarcinoma of esophagus and esophagogastric junction (EGJ) Siewert type I.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice