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NCT02499952 · BASELINE

Baseline characteristics

Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors · Source last updated 2022-07-11

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
      12
    units
    Participants
groups
  1. description
    Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
    id
    BG000
    title
    Experimental Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          lower Limit
          27
          upper Limit
          55
          value
          38
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          11
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Testis
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Retroperitoneum
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Mediastinum
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Location Of Primary Tumor
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Seminoma
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Nonseminoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Choriocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Embryonal carcinoma
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Teratoma
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Yolk sac tumor
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Predominant Histology
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      5
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      6
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Previous Chemotherapy Regimens
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        ECOG 1
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Retroperitoneum
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Pulmonary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Non Pulmonary Visceral Metastasis
    description
    The overall count of metastatic location(s). Subjects may have metastasis at multiple locations.
    param Type
    NUMBER
    title
    Metastatic Site(s)
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    units
    Participants
groups
  1. description
    Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
    id
    BG000
    title
    Experimental Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          lower Limit
          27
          upper Limit
          55
          value
          38
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          11
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Testis
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Retroperitoneum
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Mediastinum
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Location Of Primary Tumor
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Seminoma
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Nonseminoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Choriocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Embryonal carcinoma
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Teratoma
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Yolk sac tumor
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Predominant Histology
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      5
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      6
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Previous Chemotherapy Regimens
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        ECOG 1
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Retroperitoneum
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Pulmonary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Non Pulmonary Visceral Metastasis
    description
    The overall count of metastatic location(s). Subjects may have metastasis at multiple locations.
    param Type
    NUMBER
    title
    Metastatic Site(s)
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice