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NCT02054806 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) · Source last updated 2023-10-30

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
      475
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
    id
    BG000
    title
    Pembrolizumab (MK-3475) 10 mg/kg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          58.7
    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
          281
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          194
        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
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          380
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          77
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          99
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          280
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          73
        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 allocated participants who received at least one dose of study drug. Per protocol, Baseline Characteristics were summarized by treatment dose.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      475
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
    id
    BG000
    title
    Pembrolizumab (MK-3475) 10 mg/kg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          58.7
    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
          281
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          194
        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
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          380
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          77
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          99
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          280
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          73
        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 allocated participants who received at least one dose of study drug. Per protocol, Baseline Characteristics were summarized by treatment dose.

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