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NCT02612194 · BASELINE

Baseline characteristics

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer · Source last updated 2022-11-03

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
      6
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      8
    units
    Participants
groups
  1. description
    c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.
    id
    BG000
    title
    Cohort 1
  2. description
    c-MET + (10-100%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.
    id
    BG001
    title
    Cohort 2
  3. description
    c-MET null (0-9%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.
    id
    BG002
    title
    Cohort 3
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          53
          upper Limit
          77
          value
          60
        2. group Id
          BG002
          lower Limit
          64
          upper Limit
          79
          value
          71.5
        3. group Id
          BG003
          lower Limit
          53
          upper Limit
          79
          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
          2
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          6
        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
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          8
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        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
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          7
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        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
          6
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          8
      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
          5
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          6
        title
        Bladder
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          2
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Site
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          4
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          4
        title
        1
    description
    Measure Description: ECOG Scale of Performance Status, developed by the Eastern Cooperative Oncology Group, where 0 indicates subject is fully active, able to carry on all pre-disease performance without restriction and where 1 indicates subject is 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.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          1
        title
        0%
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          1
        title
        1 - 9%
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          2
        title
        51 - 75%
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          4
        title
        >75%
    description
    c-MET protein expression was assessed by immunohistochemistray as percent of tumor cells staining positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    c-MET Expression, %
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          2
        title
        0%
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          4
        title
        1 - 9%
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          2
        title
        >75%
    description
    RON protein expression was assessed by immunohistochemistray as percent of tumor cells staining positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    RON Expression, %
    unit Of Measure
    Participants
population Description
Note, there were no subjects enrolled to cohort 2 as no subjects were enrolled who were c-MET + and RON+. Therefore, no baseline results are available for Cohort 2.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      8
    units
    Participants
groups
  1. description
    c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.
    id
    BG000
    title
    Cohort 1
  2. description
    c-MET + (10-100%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.
    id
    BG001
    title
    Cohort 2
  3. description
    c-MET null (0-9%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.
    id
    BG002
    title
    Cohort 3
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          53
          upper Limit
          77
          value
          60
        2. group Id
          BG002
          lower Limit
          64
          upper Limit
          79
          value
          71.5
        3. group Id
          BG003
          lower Limit
          53
          upper Limit
          79
          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
          2
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          6
        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
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          8
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        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
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          7
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        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
          6
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          8
      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
          5
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          6
        title
        Bladder
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          2
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Site
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          4
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          4
        title
        1
    description
    Measure Description: ECOG Scale of Performance Status, developed by the Eastern Cooperative Oncology Group, where 0 indicates subject is fully active, able to carry on all pre-disease performance without restriction and where 1 indicates subject is 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.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          1
        title
        0%
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          1
        title
        1 - 9%
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          2
        title
        51 - 75%
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          4
        title
        >75%
    description
    c-MET protein expression was assessed by immunohistochemistray as percent of tumor cells staining positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    c-MET Expression, %
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          2
        title
        0%
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          4
        title
        1 - 9%
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          2
        title
        >75%
    description
    RON protein expression was assessed by immunohistochemistray as percent of tumor cells staining positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    RON Expression, %
    unit Of Measure
    Participants
population Description
Note, there were no subjects enrolled to cohort 2 as no subjects were enrolled who were c-MET + and RON+. Therefore, no baseline results are available for Cohort 2.

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Preserved source evidence · Not medical advice