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NCT02301039 · BASELINE

Baseline characteristics

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas · Source last updated 2020-09-29

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
      42
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      60
    4. group Id
      BG003
      value
      144
    units
    Participants
groups
  1. description
    Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    BG000
    title
    Soft Tissue Sarcoma
  2. description
    Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    BG001
    title
    Bone Sarcoma
  3. description
    Patients with the following types of soft tissue sarcoma: Liposarcoma and Pleomorphic sarcoma
    id
    BG002
    title
    Expansion
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          104
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          33
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          96
        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
          5
        4. group Id
          BG003
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          126
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          122
        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
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        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
      42
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      60
    4. group Id
      BG003
      value
      144
    units
    Participants
groups
  1. description
    Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    BG000
    title
    Soft Tissue Sarcoma
  2. description
    Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    BG001
    title
    Bone Sarcoma
  3. description
    Patients with the following types of soft tissue sarcoma: Liposarcoma and Pleomorphic sarcoma
    id
    BG002
    title
    Expansion
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          104
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          33
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          96
        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
          5
        4. group Id
          BG003
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          126
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          122
        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
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice