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NCT01653028 · BASELINE

Baseline characteristics

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma · Source last updated 2017-11-30

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
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      11
    4. group Id
      BG003
      value
      10
    5. group Id
      BG004
      value
      29
    6. group Id
      BG005
      value
      72
    units
    Participants
groups
  1. description
    Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Cohort 1
  2. description
    Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Cohort 2
  3. description
    Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Cohort 3
  4. description
    Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG003
    title
    Cohort4
  5. description
    Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    Cohort 5
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          72
          value
          61
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          84
          value
          56.5
        3. group Id
          BG002
          lower Limit
          49
          upper Limit
          76
          value
          66
        4. group Id
          BG003
          lower Limit
          29
          upper Limit
          71
          value
          52.5
        5. group Id
          BG004
          lower Limit
          20
          upper Limit
          83
          value
          49
        6. group Id
          BG005
          lower Limit
          20
          upper Limit
          84
          value
          54.5
    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
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          39
        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
          1
        6. group Id
          BG005
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        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
          3
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          61
        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
        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
          1
        6. group Id
          BG005
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          72
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      11
    4. group Id
      BG003
      value
      10
    5. group Id
      BG004
      value
      29
    6. group Id
      BG005
      value
      72
    units
    Participants
groups
  1. description
    Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Cohort 1
  2. description
    Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Cohort 2
  3. description
    Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Cohort 3
  4. description
    Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG003
    title
    Cohort4
  5. description
    Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    Cohort 5
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          72
          value
          61
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          84
          value
          56.5
        3. group Id
          BG002
          lower Limit
          49
          upper Limit
          76
          value
          66
        4. group Id
          BG003
          lower Limit
          29
          upper Limit
          71
          value
          52.5
        5. group Id
          BG004
          lower Limit
          20
          upper Limit
          83
          value
          49
        6. group Id
          BG005
          lower Limit
          20
          upper Limit
          84
          value
          54.5
    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
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          39
        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
          1
        6. group Id
          BG005
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        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
          3
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          61
        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
        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
          1
        6. group Id
          BG005
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          72
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice