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NCT02702414 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Advanced Hepatocellular Carcinoma (MK-3475-224/KEYNOTE-224) · Source last updated 2024-09-04

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
      105
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      156
    units
    Participants
groups
  1. description
    Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    BG000
    title
    Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
  2. description
    Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    BG001
    title
    Cohort 2: HCC-Systemic Therapy Naïve
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.2
          value
          67.4
        2. group Id
          BG001
          spread
          10.3
          value
          67.7
        3. group Id
          BG002
          spread
          8.8
          value
          67.6
    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
          19
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          130
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          144
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        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
          14
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        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
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          133
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All allocated participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      105
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      156
    units
    Participants
groups
  1. description
    Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    BG000
    title
    Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
  2. description
    Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    BG001
    title
    Cohort 2: HCC-Systemic Therapy Naïve
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.2
          value
          67.4
        2. group Id
          BG001
          spread
          10.3
          value
          67.7
        3. group Id
          BG002
          spread
          8.8
          value
          67.6
    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
          19
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          130
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          144
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        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
          14
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        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
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          133
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All allocated participants

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Preserved source evidence · Not medical advice