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NCT03189719 · BASELINE

Baseline characteristics

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590) · Source last updated 2024-10-15

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
      373
    2. group Id
      BG001
      value
      376
    3. group Id
      BG002
      value
      749
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
    id
    BG000
    title
    Pembrolizumab + SOC
  2. description
    Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
    id
    BG001
    title
    Placebo + SOC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          62.8
        2. group Id
          BG001
          spread
          9.2
          value
          62.0
        3. group Id
          BG002
          spread
          9.5
          value
          62.4
    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
          67
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          124
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          306
        2. group Id
          BG001
          value
          319
        3. group Id
          BG002
          value
          625
        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
          42
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          99
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          315
        2. group Id
          BG001
          value
          296
        3. group Id
          BG002
          value
          611
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          39
        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
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          199
        3. group Id
          BG002
          value
          400
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          139
        3. group Id
          BG002
          value
          278
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        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
          196
        2. group Id
          BG001
          value
          197
        3. group Id
          BG002
          value
          393
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          356
        title
        Rest of World
    description
    Participants were stratified according to Geographic Region of enrolling site (Asia versus Rest of World)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          201
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          274
        2. group Id
          BG001
          value
          274
        3. group Id
          BG002
          value
          548
        title
        Squamous Cell Carcinoma
    description
    Participants were stratified according to baseline Histology (adenocarcinoma versus squamous cell carcinoma)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          299
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          223
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          448
        title
        ECOG PS 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        ECOG PS 2
    description
    ECOG PS 0 = Fully active, able to carry on all pre-disease performance without restriction), ECOG PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, ECOG PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. Participants were stratified according to baseline ECOG PS (0 versus 1).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Group Performance Status (ECOG PS)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      373
    2. group Id
      BG001
      value
      376
    3. group Id
      BG002
      value
      749
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
    id
    BG000
    title
    Pembrolizumab + SOC
  2. description
    Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
    id
    BG001
    title
    Placebo + SOC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          62.8
        2. group Id
          BG001
          spread
          9.2
          value
          62.0
        3. group Id
          BG002
          spread
          9.5
          value
          62.4
    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
          67
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          124
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          306
        2. group Id
          BG001
          value
          319
        3. group Id
          BG002
          value
          625
        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
          42
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          99
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          315
        2. group Id
          BG001
          value
          296
        3. group Id
          BG002
          value
          611
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          39
        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
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          199
        3. group Id
          BG002
          value
          400
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          139
        3. group Id
          BG002
          value
          278
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        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
          196
        2. group Id
          BG001
          value
          197
        3. group Id
          BG002
          value
          393
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          356
        title
        Rest of World
    description
    Participants were stratified according to Geographic Region of enrolling site (Asia versus Rest of World)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          201
        title
        Adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          274
        2. group Id
          BG001
          value
          274
        3. group Id
          BG002
          value
          548
        title
        Squamous Cell Carcinoma
    description
    Participants were stratified according to baseline Histology (adenocarcinoma versus squamous cell carcinoma)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          299
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          223
        2. group Id
          BG001
          value
          225
        3. group Id
          BG002
          value
          448
        title
        ECOG PS 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        ECOG PS 2
    description
    ECOG PS 0 = Fully active, able to carry on all pre-disease performance without restriction), ECOG PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, ECOG PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. Participants were stratified according to baseline ECOG PS (0 versus 1).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Group Performance Status (ECOG PS)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice