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NCT02042443 · BASELINE

Baseline characteristics

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery · Source last updated 2017-09-12

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
      24
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      44
    units
    Participants
groups
  1. description
    Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Trametinib
  2. description
    Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          78
          value
          63
        2. group Id
          BG001
          lower Limit
          41
          upper Limit
          81
          value
          61
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          81
          value
          62
    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
          18
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          15
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          39
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          31
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
      title
      5FU/LV
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          31
      title
      Capecitabine
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Planned Chemotherapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
      title
      Cholangiocarcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      Gall bladder
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of Disease
    unit Of Measure
    Participants
population Description
All eligible and analyzable patients are included.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      44
    units
    Participants
groups
  1. description
    Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Trametinib
  2. description
    Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          78
          value
          63
        2. group Id
          BG001
          lower Limit
          41
          upper Limit
          81
          value
          61
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          81
          value
          62
    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
          18
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          15
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          39
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          31
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
      title
      5FU/LV
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          31
      title
      Capecitabine
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Planned Chemotherapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
      title
      Cholangiocarcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      Gall bladder
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of Disease
    unit Of Measure
    Participants
population Description
All eligible and analyzable patients are included.

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Preserved source evidence · Not medical advice