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NCT02643303 · BASELINE

Baseline characteristics

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers · Source last updated 2022-12-02

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
      4
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      15
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      3
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      56
    units
    Participants
groups
  1. description
    Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC
    id
    BG000
    title
    Phase 1, Cohort 1A
  2. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG001
    title
    Phase 1, Cohort 1B
  3. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG002
    title
    Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
  4. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG003
    title
    Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
  5. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG004
    title
    Cohort 1C + Phase 2; Sarcoma
  6. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG005
    title
    Cohort 1C + Phase 2; Merkel Cell Carcinoma
  7. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG006
    title
    Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
  8. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG007
    title
    Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
  9. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG008
    title
    Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          70
          value
          52.5
        2. group Id
          BG001
          lower Limit
          26
          upper Limit
          69
          value
          55
        3. group Id
          BG002
          lower Limit
          66
          upper Limit
          66
          value
          66
        4. group Id
          BG003
          lower Limit
          39
          upper Limit
          71
          value
          59
        5. group Id
          BG004
          lower Limit
          21
          upper Limit
          68
          value
          51
        6. group Id
          BG005
          lower Limit
          46
          upper Limit
          71
          value
          66
        7. group Id
          BG006
          lower Limit
          34
          upper Limit
          84
          value
          64
        8. group Id
          BG007
          lower Limit
          45
          upper Limit
          55
          value
          54
        9. group Id
          BG008
          lower Limit
          31
          upper Limit
          80
          value
          58
        10. group Id
          BG009
          lower Limit
          21
          upper Limit
          84
          value
          58
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          20
        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
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          54
        title
        Not Hispanic or Latino
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          45
        title
        White
      6. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          56
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          23
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          33
        title
        ECOG PS 1
    description
    PS 0 = Fully active, able to carry on all pre-disease performance without restriction; PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; PS 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; PS 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; PS 5 = Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
population Description
All subjects who received at least one dose of study medication.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      15
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      3
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      56
    units
    Participants
groups
  1. description
    Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC
    id
    BG000
    title
    Phase 1, Cohort 1A
  2. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG001
    title
    Phase 1, Cohort 1B
  3. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG002
    title
    Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
  4. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG003
    title
    Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
  5. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG004
    title
    Cohort 1C + Phase 2; Sarcoma
  6. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG005
    title
    Cohort 1C + Phase 2; Merkel Cell Carcinoma
  7. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG006
    title
    Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
  8. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG007
    title
    Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
  9. description
    Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
    id
    BG008
    title
    Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          70
          value
          52.5
        2. group Id
          BG001
          lower Limit
          26
          upper Limit
          69
          value
          55
        3. group Id
          BG002
          lower Limit
          66
          upper Limit
          66
          value
          66
        4. group Id
          BG003
          lower Limit
          39
          upper Limit
          71
          value
          59
        5. group Id
          BG004
          lower Limit
          21
          upper Limit
          68
          value
          51
        6. group Id
          BG005
          lower Limit
          46
          upper Limit
          71
          value
          66
        7. group Id
          BG006
          lower Limit
          34
          upper Limit
          84
          value
          64
        8. group Id
          BG007
          lower Limit
          45
          upper Limit
          55
          value
          54
        9. group Id
          BG008
          lower Limit
          31
          upper Limit
          80
          value
          58
        10. group Id
          BG009
          lower Limit
          21
          upper Limit
          84
          value
          58
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          20
        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
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          54
        title
        Not Hispanic or Latino
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          45
        title
        White
      6. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          56
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          23
        title
        ECOG PS 0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          33
        title
        ECOG PS 1
    description
    PS 0 = Fully active, able to carry on all pre-disease performance without restriction; PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; PS 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; PS 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; PS 5 = Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
population Description
All subjects who received at least one dose of study medication.

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