Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03673124 · BASELINE

Baseline characteristics

Ribociclib and Letrozole Treatment in Ovarian Cancer · Source last updated 2025-12-23

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
      49
    units
    Participants
groups
  1. description
    Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days. Treatment continues until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Ribociclib and Letrozole
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        20-29
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        30-39
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        40-49
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        50-59
      5. measurements
        1. group Id
          BG000
          value
          17
        title
        60-69
      6. measurements
        1. group Id
          BG000
          value
          6
        title
        70-79
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        80-89
      title
      Age (Years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        Black
      2. measurements
        1. group Id
          BG000
          value
          44
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Declined to Report
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          38
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Declined to Report
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Not Reported
    description
    ECOG 0 is fully active, able to carry on all pre-disease performance without restriction. ECOG 1 is 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.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status (ECOG)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        title
        Ovary
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Peritoneum
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of Disease
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          36
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          9
        title
        IV
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Not Reported
    description
    FIGO stage at diagnosis was reported by each participant institution according to their standard practice. In general, a higher FIGO stage indicates more advanced disease.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FIGO Stage at Diagnosis (ohr)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Surgery
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Radiation Therapy (ohr)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Any Prior Immunologic/Chemo/Hormonal/Biologic/Antiangiogenic/Other therapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          7
        title
        4
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        5
      7. measurements
        1. group Id
          BG000
          value
          5
        title
        6 or more
    description
    Any immunologic/chemo/hormonal/biologic/antiangiogenic/other therapy reported by participation sites, where a line of therapy was defined by the participation sites' standards.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lines of Prior Therapy (ohr)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      49
    units
    Participants
groups
  1. description
    Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days. Treatment continues until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Ribociclib and Letrozole
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        20-29
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        30-39
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        40-49
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        50-59
      5. measurements
        1. group Id
          BG000
          value
          17
        title
        60-69
      6. measurements
        1. group Id
          BG000
          value
          6
        title
        70-79
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        80-89
      title
      Age (Years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        Black
      2. measurements
        1. group Id
          BG000
          value
          44
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Declined to Report
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          38
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Declined to Report
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Not Reported
    description
    ECOG 0 is fully active, able to carry on all pre-disease performance without restriction. ECOG 1 is 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.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status (ECOG)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        title
        Ovary
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Peritoneum
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of Disease
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          36
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          9
        title
        IV
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Not Reported
    description
    FIGO stage at diagnosis was reported by each participant institution according to their standard practice. In general, a higher FIGO stage indicates more advanced disease.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FIGO Stage at Diagnosis (ohr)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Surgery
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Radiation Therapy (ohr)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        No
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Yes
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Any Prior Immunologic/Chemo/Hormonal/Biologic/Antiangiogenic/Other therapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          7
        title
        4
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        5
      7. measurements
        1. group Id
          BG000
          value
          5
        title
        6 or more
    description
    Any immunologic/chemo/hormonal/biologic/antiangiogenic/other therapy reported by participation sites, where a line of therapy was defined by the participation sites' standards.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lines of Prior Therapy (ohr)
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice