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NCT02335424 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052) · Source last updated 2023-03-02

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
      374
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
    id
    BG000
    title
    Pembrolizumab 200 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.9
          value
          73.0
    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
          86
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          288
        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
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          326
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          26
        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
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          332
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The baseline analysis population consisted of all allocated participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      374
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
    id
    BG000
    title
    Pembrolizumab 200 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.9
          value
          73.0
    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
          86
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          288
        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
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          326
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          26
        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
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          332
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The baseline analysis population consisted of all allocated participants.

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Preserved source evidence · Not medical advice