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NCT03062358 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394) · Source last updated 2025-09-30

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
      300
    2. group Id
      BG001
      value
      153
    3. group Id
      BG002
      value
      453
    units
    Participants
groups
  1. description
    Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    BG000
    title
    Pembrolizumab + BSC
  2. description
    Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    BG001
    title
    Placebo + BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.1
          value
          54.6
        2. group Id
          BG001
          spread
          12.9
          value
          52.0
        3. group Id
          BG002
          spread
          12.4
          value
          53.7
    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
          43
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          383
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          453
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          453
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          33
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          50
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          267
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          403
      title
      No
    description
    Per Case Report Form
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Macrovascular Invasion
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          206
      title
      < 200 ng/mL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          247
      title
      ≥ 200 ng/mL
    description
    Per Lab
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alpha-Fetoprotein (α-Fetoprotein)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          387
      title
      China
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          66
      title
      Ex-China
    description
    China comprises: China mainland, Hong Kong, and Taiwan; Ex-China comprises: South Korea and Malaysia.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      300
    2. group Id
      BG001
      value
      153
    3. group Id
      BG002
      value
      453
    units
    Participants
groups
  1. description
    Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    BG000
    title
    Pembrolizumab + BSC
  2. description
    Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    BG001
    title
    Placebo + BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.1
          value
          54.6
        2. group Id
          BG001
          spread
          12.9
          value
          52.0
        3. group Id
          BG002
          spread
          12.4
          value
          53.7
    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
          43
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          383
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          453
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          453
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          33
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          50
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          267
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          403
      title
      No
    description
    Per Case Report Form
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Macrovascular Invasion
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          206
      title
      < 200 ng/mL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          247
      title
      ≥ 200 ng/mL
    description
    Per Lab
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Alpha-Fetoprotein (α-Fetoprotein)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          387
      title
      China
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          66
      title
      Ex-China
    description
    China comprises: China mainland, Hong Kong, and Taiwan; Ex-China comprises: South Korea and Malaysia.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice