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NCT02422615 · BASELINE

Baseline characteristics

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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
      484
    2. group Id
      BG001
      value
      242
    3. group Id
      BG002
      value
      726
    units
    Participants
groups
  1. description
    Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    BG000
    title
    Ribociclib + Fulvestrant
  2. description
    Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.
    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
          9.78
          value
          63.4
        2. group Id
          BG001
          spread
          10.59
          value
          62.8
        3. group Id
          BG002
          spread
          10.05
          value
          63.2
    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
          484
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          726
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          406
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          619
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          63
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
      title
      Native American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Black
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          20
      title
      Unkown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      484
    2. group Id
      BG001
      value
      242
    3. group Id
      BG002
      value
      726
    units
    Participants
groups
  1. description
    Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    BG000
    title
    Ribociclib + Fulvestrant
  2. description
    Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.
    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
          9.78
          value
          63.4
        2. group Id
          BG001
          spread
          10.59
          value
          62.8
        3. group Id
          BG002
          spread
          10.05
          value
          63.2
    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
          484
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          726
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          406
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          619
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          63
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
      title
      Native American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Black
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          20
      title
      Unkown
    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