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NCT02278120 · BASELINE

Baseline characteristics

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer · Source last updated 2024-03-12

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
      335
    2. group Id
      BG001
      value
      337
    3. group Id
      BG002
      value
      672
    units
    Participants
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
    id
    BG000
    title
    Ribociclib + NSAI/Tamoxifen + Goserelin
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin
    id
    BG001
    title
    Placebo + NSAI/Tamoxifen+ Goserelin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.6
          value
          42.6
        2. group Id
          BG001
          spread
          6.17
          value
          43.7
        3. group Id
          BG002
          spread
          6.4
          value
          43.1
    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
          335
        2. group Id
          BG001
          value
          337
        3. group Id
          BG002
          value
          672
        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
          187
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          388
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          198
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          23
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
      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
      335
    2. group Id
      BG001
      value
      337
    3. group Id
      BG002
      value
      672
    units
    Participants
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
    id
    BG000
    title
    Ribociclib + NSAI/Tamoxifen + Goserelin
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin
    id
    BG001
    title
    Placebo + NSAI/Tamoxifen+ Goserelin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.6
          value
          42.6
        2. group Id
          BG001
          spread
          6.17
          value
          43.7
        3. group Id
          BG002
          spread
          6.4
          value
          43.1
    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
          335
        2. group Id
          BG001
          value
          337
        3. group Id
          BG002
          value
          672
        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
          187
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          388
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          198
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          23
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
      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