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NCT02494583 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062) · Source last updated 2023-04-13

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
      256
    2. group Id
      BG001
      value
      257
    3. group Id
      BG002
      value
      250
    4. group Id
      BG003
      value
      763
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). 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
    BG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. 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
    BG001
    title
    Pembrolizumab + SOC Chemotherapy (Pembro Combo)
  3. description
    Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    BG002
    title
    Placebo + SOC Chemotherapy (SOC)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          59.9
        2. group Id
          BG001
          spread
          11.6
          value
          60.9
        3. group Id
          BG002
          spread
          12.7
          value
          60.7
        4. group Id
          BG003
          spread
          12.0
          value
          60.5
    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
          76
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          71
        4. group Id
          BG003
          value
          209
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          180
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          554
        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
          45
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          145
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          197
        4. group Id
          BG003
          value
          599
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          19
        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
          7
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          29
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          207
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          154
        4. group Id
          BG003
          value
          485
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          22
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        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
          148
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          147
        4. group Id
          BG003
          value
          443
      title
      Europe/North America/Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          61
        4. group Id
          BG003
          value
          187
      title
      Asia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          133
      title
      Rest of the World
    description
    Participants were stratified according to geographic region of enrolling site: Europe (including Israel)/North America/Australia, Asia (including East Asia \[South Korea, Hong Kong, Taiwan\], South East Asia \[Malaysia\], Thailand, Singapore, Japan), or Rest of the World (including South America).
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          35
        title
        Locally advanced
      2. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          723
        title
        Metastatic
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Missing
    description
    Participants were stratified according to gastric cancer disease status as either locally advanced unresectable or metastatic disease.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          290
        title
        5-FU
      2. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          155
        4. group Id
          BG003
          value
          473
        title
        Capecitabine
    description
    Participants receiving SOC chemotherapy were stratified according to fluoropyrimidine treatment (5-FU or capecitabine).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Fluoropyrimidine Treatment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      256
    2. group Id
      BG001
      value
      257
    3. group Id
      BG002
      value
      250
    4. group Id
      BG003
      value
      763
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). 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
    BG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. 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
    BG001
    title
    Pembrolizumab + SOC Chemotherapy (Pembro Combo)
  3. description
    Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    BG002
    title
    Placebo + SOC Chemotherapy (SOC)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          59.9
        2. group Id
          BG001
          spread
          11.6
          value
          60.9
        3. group Id
          BG002
          spread
          12.7
          value
          60.7
        4. group Id
          BG003
          spread
          12.0
          value
          60.5
    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
          76
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          71
        4. group Id
          BG003
          value
          209
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          180
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          554
        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
          45
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          145
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          197
        4. group Id
          BG003
          value
          599
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          19
        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
          7
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          29
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          207
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          154
        4. group Id
          BG003
          value
          485
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          22
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        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
          148
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          147
        4. group Id
          BG003
          value
          443
      title
      Europe/North America/Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          61
        4. group Id
          BG003
          value
          187
      title
      Asia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          133
      title
      Rest of the World
    description
    Participants were stratified according to geographic region of enrolling site: Europe (including Israel)/North America/Australia, Asia (including East Asia \[South Korea, Hong Kong, Taiwan\], South East Asia \[Malaysia\], Thailand, Singapore, Japan), or Rest of the World (including South America).
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          35
        title
        Locally advanced
      2. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          723
        title
        Metastatic
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Missing
    description
    Participants were stratified according to gastric cancer disease status as either locally advanced unresectable or metastatic disease.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          290
        title
        5-FU
      2. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          155
        4. group Id
          BG003
          value
          473
        title
        Capecitabine
    description
    Participants receiving SOC chemotherapy were stratified according to fluoropyrimidine treatment (5-FU or capecitabine).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Fluoropyrimidine Treatment
    unit Of Measure
    Participants

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