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NCT03284424 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) · Source last updated 2024-08-23

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
      54
    3. group Id
      BG002
      value
      159
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab 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
    Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort
  2. description
    Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab 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
    Locally Advanced Unresectable cSCC Cohort
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.3
          value
          70.0
        2. group Id
          BG001
          spread
          12.4
          value
          73.7
        3. group Id
          BG002
          spread
          13.8
          value
          71.3
    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
          15
        3. group Id
          BG002
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          119
        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
          13
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          97
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          47
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          108
        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
          32
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          44
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      105
    2. group Id
      BG001
      value
      54
    3. group Id
      BG002
      value
      159
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab 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
    Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort
  2. description
    Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). Eligible participants who stopped the initial course of pembrolizumab 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
    Locally Advanced Unresectable cSCC Cohort
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.3
          value
          70.0
        2. group Id
          BG001
          spread
          12.4
          value
          73.7
        3. group Id
          BG002
          spread
          13.8
          value
          71.3
    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
          15
        3. group Id
          BG002
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          119
        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
          13
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          97
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          47
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          108
        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
          32
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          44
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.

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Preserved source evidence · Not medical advice