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NCT02460198 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164) · Source last updated 2023-07-27

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
      61
    2. group Id
      BG001
      value
      63
    3. group Id
      BG002
      value
      124
    units
    Participants
groups
  1. description
    Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
    id
    BG000
    title
    Cohort A - Pembrolizumab 200 mg
  2. description
    Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
    id
    BG001
    title
    Cohort B - Pembrolizumab 200 mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.5
          value
          54.3
        2. group Id
          BG001
          spread
          15.2
          value
          57.8
        3. group Id
          BG002
          spread
          14.9
          value
          56.1
    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
          25
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          55
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          69
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          119
        title
        Not Hispanic or Latino
      3. 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
    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
          19
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          33
        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
          7
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          84
        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
population Description
The analysis population included all randomized and treated participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      61
    2. group Id
      BG001
      value
      63
    3. group Id
      BG002
      value
      124
    units
    Participants
groups
  1. description
    Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
    id
    BG000
    title
    Cohort A - Pembrolizumab 200 mg
  2. description
    Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
    id
    BG001
    title
    Cohort B - Pembrolizumab 200 mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.5
          value
          54.3
        2. group Id
          BG001
          spread
          15.2
          value
          57.8
        3. group Id
          BG002
          spread
          14.9
          value
          56.1
    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
          25
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          55
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          69
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          119
        title
        Not Hispanic or Latino
      3. 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
    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
          19
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          33
        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
          7
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          84
        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
population Description
The analysis population included all randomized and treated participants.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice