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NCT01844986 · BASELINE

Baseline characteristics

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. · Source last updated 2025-12-10

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
      300
    2. group Id
      BG001
      value
      150
    3. group Id
      BG002
      value
      450
    units
    Participants
groups
  1. description
    Taken orally twice daily
    id
    BG000
    title
    Olaparib 300mg Tablets (Global Cohort & China Cohort)
  2. description
    Taken orally twice daily
    id
    BG001
    title
    Placebo Tablets (Global Cohort & China Cohort)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.38
          value
          53.6
        2. group Id
          BG001
          spread
          9.79
          value
          53.4
        3. group Id
          BG002
          spread
          9.51
          value
          53.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.27
          value
          50.7
        2. group Id
          BG001
          spread
          7.95
          value
          51.5
        3. group Id
          BG002
          spread
          7.44
          value
          51.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          59
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          320
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          320
        title
        Complete Response
      2. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          71
        title
        Partial Response
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          55
        title
        Complete Response
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Partial Response
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Response to previous platinum chemotherapy (as randomised)
    unit Of Measure
    Participants
population Description
Global Cohort (391 subjects): 260 Olaparib 131 Placebo China Cohort (64 subjects): 44 Olaparib 20 Placebo Included in both cohorts (5 subjects): 4 Olaparib 1 Placebo Total (450 subjects): 300 Olaparib 150 Placebo
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      300
    2. group Id
      BG001
      value
      150
    3. group Id
      BG002
      value
      450
    units
    Participants
groups
  1. description
    Taken orally twice daily
    id
    BG000
    title
    Olaparib 300mg Tablets (Global Cohort & China Cohort)
  2. description
    Taken orally twice daily
    id
    BG001
    title
    Placebo Tablets (Global Cohort & China Cohort)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.38
          value
          53.6
        2. group Id
          BG001
          spread
          9.79
          value
          53.4
        3. group Id
          BG002
          spread
          9.51
          value
          53.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.27
          value
          50.7
        2. group Id
          BG001
          spread
          7.95
          value
          51.5
        3. group Id
          BG002
          spread
          7.44
          value
          51.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          59
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          320
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          320
        title
        Complete Response
      2. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          71
        title
        Partial Response
      denoms
      1. counts
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          391
        units
        Participants
      title
      Global Cohort
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          55
        title
        Complete Response
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Partial Response
      denoms
      1. counts
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          64
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
    title
    Response to previous platinum chemotherapy (as randomised)
    unit Of Measure
    Participants
population Description
Global Cohort (391 subjects): 260 Olaparib 131 Placebo China Cohort (64 subjects): 44 Olaparib 20 Placebo Included in both cohorts (5 subjects): 4 Olaparib 1 Placebo Total (450 subjects): 300 Olaparib 150 Placebo

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Preserved source evidence · Not medical advice