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NCT01958021 · BASELINE

Baseline characteristics

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer · Source last updated 2025-03-07

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
      334
    2. group Id
      BG001
      value
      334
    3. group Id
      BG002
      value
      668
    units
    Participants
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
    id
    BG000
    title
    Ribociclib + Letrozole
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
    id
    BG001
    title
    Placebo + Letrozole
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.98
          value
          61.4
        2. group Id
          BG001
          spread
          10.52
          value
          61.9
        3. group Id
          BG002
          spread
          10.75
          value
          61.6
    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
          334
        2. group Id
          BG001
          value
          334
        3. group Id
          BG002
          value
          668
        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
          269
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          549
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          51
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        title
        Black
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          29
        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
      334
    2. group Id
      BG001
      value
      334
    3. group Id
      BG002
      value
      668
    units
    Participants
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
    id
    BG000
    title
    Ribociclib + Letrozole
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
    id
    BG001
    title
    Placebo + Letrozole
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.98
          value
          61.4
        2. group Id
          BG001
          spread
          10.52
          value
          61.9
        3. group Id
          BG002
          spread
          10.75
          value
          61.6
    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
          334
        2. group Id
          BG001
          value
          334
        3. group Id
          BG002
          value
          668
        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
          269
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          549
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          51
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        title
        Black
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          29
        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