Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02187783 · BASELINE

Baseline characteristics

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) · Source last updated 2019-07-18

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
      106
    units
    Participants
groups
  1. description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    BG000
    title
    Ribociclib 600 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.52
          value
          60.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        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
          90
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Adrenals
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Bladder
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        Breast-triple negative
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Cervix
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Cholangio
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Chordoma
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Colorectal
      8. measurements
        1. group Id
          BG000
          value
          3
        title
        Esophagus
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        Gall bladder ducts
      10. measurements
        1. group Id
          BG000
          value
          4
        title
        Gastroesophageal junction
      11. measurements
        1. group Id
          BG000
          value
          1
        title
        Gastrointestinal stromal tumor
      12. measurements
        1. group Id
          BG000
          value
          4
        title
        Head and neck non-squamous cell carcinoma
    description
    Primary tumor type was sponsor adjudicated.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary tumor type
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
      title
      Prior antineoplastic radiotherapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          92
      title
      Prior antineoplastic surgery
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      title
      Liver metastasis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of participants who had radiotherapy, surgery and liver metastasis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Performance status = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          70
      title
      Performance status = 1
    description
    ECOG: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status for participants
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      106
    units
    Participants
groups
  1. description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    BG000
    title
    Ribociclib 600 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.52
          value
          60.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        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
          90
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Adrenals
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Bladder
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        Breast-triple negative
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Cervix
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Cholangio
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Chordoma
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Colorectal
      8. measurements
        1. group Id
          BG000
          value
          3
        title
        Esophagus
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        Gall bladder ducts
      10. measurements
        1. group Id
          BG000
          value
          4
        title
        Gastroesophageal junction
      11. measurements
        1. group Id
          BG000
          value
          1
        title
        Gastrointestinal stromal tumor
      12. measurements
        1. group Id
          BG000
          value
          4
        title
        Head and neck non-squamous cell carcinoma
    description
    Primary tumor type was sponsor adjudicated.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary tumor type
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
      title
      Prior antineoplastic radiotherapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          92
      title
      Prior antineoplastic surgery
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      title
      Liver metastasis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of participants who had radiotherapy, surgery and liver metastasis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Performance status = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          70
      title
      Performance status = 1
    description
    ECOG: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status for participants
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice