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NCT02555657 · BASELINE

Baseline characteristics

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) · Source last updated 2021-12-10

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
      312
    2. group Id
      BG001
      value
      310
    3. group Id
      BG002
      value
      622
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Qualified participants who received first course of pembrolizumab but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          51.4
        2. group Id
          BG001
          spread
          11.2
          value
          52.6
        3. group Id
          BG002
          spread
          11.3
          value
          52.0
    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
          312
        2. group Id
          BG001
          value
          308
        3. group Id
          BG002
          value
          620
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          188
        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
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          183
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          363
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          22
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      312
    2. group Id
      BG001
      value
      310
    3. group Id
      BG002
      value
      622
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years). Qualified participants who received first course of pembrolizumab but continued to experience disease progression may have, at investigator's discretion, initiated a second course of pembrolizumab at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          51.4
        2. group Id
          BG001
          spread
          11.2
          value
          52.6
        3. group Id
          BG002
          spread
          11.3
          value
          52.0
    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
          312
        2. group Id
          BG001
          value
          308
        3. group Id
          BG002
          value
          620
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          188
        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
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          183
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          363
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          22
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice