Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02437318 · BASELINE

Baseline characteristics

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. · Source last updated 2025-02-13

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
      284
    2. group Id
      BG001
      value
      288
    3. group Id
      BG002
      value
      572
    units
    Participants
groups
  1. description
    Subjects treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    BG000
    title
    Alpelisib + Fulvestrant
  2. description
    Subjects treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    BG001
    title
    Placebo + Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.74
          value
          62.6
        2. group Id
          BG001
          spread
          10.26
          value
          63.3
        3. group Id
          BG002
          spread
          10.00
          value
          63.0
    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
          283
        2. group Id
          BG001
          value
          288
        3. group Id
          BG002
          value
          571
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          199
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          377
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          125
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          26
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      284
    2. group Id
      BG001
      value
      288
    3. group Id
      BG002
      value
      572
    units
    Participants
groups
  1. description
    Subjects treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    BG000
    title
    Alpelisib + Fulvestrant
  2. description
    Subjects treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
    id
    BG001
    title
    Placebo + Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.74
          value
          62.6
        2. group Id
          BG001
          spread
          10.26
          value
          63.3
        3. group Id
          BG002
          spread
          10.00
          value
          63.0
    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
          283
        2. group Id
          BG001
          value
          288
        3. group Id
          BG002
          value
          571
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          199
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          377
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          125
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          26
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice