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NCT01848834 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012) · Source last updated 2021-06-28

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
      32
    2. group Id
      BG001
      value
      61
    3. group Id
      BG002
      value
      33
    4. group Id
      BG003
      value
      39
    5. group Id
      BG004
      value
      132
    6. group Id
      BG005
      value
      297
    units
    Participants
groups
  1. description
    Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG000
    title
    Cohort A: Triple Negative Breast Cancer
  2. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG001
    title
    Cohort B: Head & Neck Cancer
  3. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG002
    title
    Cohort C: Urothelial Cancer
  4. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG003
    title
    Cohort D: Gastric Cancer
  5. description
    Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG004
    title
    Cohort B2: Head & Neck Cancer Expansion
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.1
          value
          51.9
        2. group Id
          BG001
          spread
          11.5
          value
          61.5
        3. group Id
          BG002
          spread
          10.3
          value
          68.5
        4. group Id
          BG003
          spread
          13.2
          value
          58.3
        5. group Id
          BG004
          spread
          9.7
          value
          58.9
        6. group Id
          BG005
          spread
          11.6
          value
          59.7
    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
          32
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          22
        6. group Id
          BG005
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          110
        6. group Id
          BG005
          value
          210
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          108
        6. group Id
          BG005
          value
          255
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          30
        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
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          48
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          19
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          95
        6. group Id
          BG005
          value
          223
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        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
      32
    2. group Id
      BG001
      value
      61
    3. group Id
      BG002
      value
      33
    4. group Id
      BG003
      value
      39
    5. group Id
      BG004
      value
      132
    6. group Id
      BG005
      value
      297
    units
    Participants
groups
  1. description
    Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG000
    title
    Cohort A: Triple Negative Breast Cancer
  2. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG001
    title
    Cohort B: Head & Neck Cancer
  3. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG002
    title
    Cohort C: Urothelial Cancer
  4. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG003
    title
    Cohort D: Gastric Cancer
  5. description
    Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    BG004
    title
    Cohort B2: Head & Neck Cancer Expansion
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.1
          value
          51.9
        2. group Id
          BG001
          spread
          11.5
          value
          61.5
        3. group Id
          BG002
          spread
          10.3
          value
          68.5
        4. group Id
          BG003
          spread
          13.2
          value
          58.3
        5. group Id
          BG004
          spread
          9.7
          value
          58.9
        6. group Id
          BG005
          spread
          11.6
          value
          59.7
    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
          32
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          22
        6. group Id
          BG005
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          110
        6. group Id
          BG005
          value
          210
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          108
        6. group Id
          BG005
          value
          255
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          30
        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
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          48
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          19
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          95
        6. group Id
          BG005
          value
          223
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        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.

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

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