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NCT01874353 · FLOW

Participant flow

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy · Source last updated 2026-07-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Taken orally twice daily
    id
    FG000
    title
    Olaparib 300mg Tablets (Global Cohort)
  2. description
    Taken orally twice daily
    id
    FG001
    title
    Placebo Tablets (Global Cohort)
  3. description
    Taken orally twice daily
    id
    FG002
    title
    Olaparib 300mg Tablets (China Cohort)
  4. description
    Taken orally twice daily
    id
    FG003
    title
    Placebo Tablets (China Cohort)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      One patient was unblinded and one patient was randomised in error
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        60
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        7
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        196
      2. group Id
        FG001
        num Subjects
        99
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        73
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
It was planned that approximately 264 women from the Global Cohort and 33 women from the China Cohort, with BRCA mutated relapsed ovarian cancer who are in complete or partial response following platinum based chemotherapy, were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.
recruitment Details
Global Cohort: First patient screened: 03 Sep 2013; last patient screened on 21 Nov 2014. 602 patients screened across 119 centres in 16 countries; 295 were randomized. Results are reported for analysis of PFS (DCO: 19 Sep 2016) and OS (DCO: 03 Feb 2020). China Cohort: First patient enrolled: 07 Apr 2015; last patient enrolled: 30 Oct 2015. 127 patients screened across 16 sites; 32 were randomized. Results are reported for analysis of PFS (DCO: 16 Jan 2017) and OS (DCO: 03 Feb 2020).
Complete source fields
groups
  1. description
    Taken orally twice daily
    id
    FG000
    title
    Olaparib 300mg Tablets (Global Cohort)
  2. description
    Taken orally twice daily
    id
    FG001
    title
    Placebo Tablets (Global Cohort)
  3. description
    Taken orally twice daily
    id
    FG002
    title
    Olaparib 300mg Tablets (China Cohort)
  4. description
    Taken orally twice daily
    id
    FG003
    title
    Placebo Tablets (China Cohort)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      One patient was unblinded and one patient was randomised in error
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        60
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        7
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        196
      2. group Id
        FG001
        num Subjects
        99
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        73
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
It was planned that approximately 264 women from the Global Cohort and 33 women from the China Cohort, with BRCA mutated relapsed ovarian cancer who are in complete or partial response following platinum based chemotherapy, were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.
recruitment Details
Global Cohort: First patient screened: 03 Sep 2013; last patient screened on 21 Nov 2014. 602 patients screened across 119 centres in 16 countries; 295 were randomized. Results are reported for analysis of PFS (DCO: 19 Sep 2016) and OS (DCO: 03 Feb 2020). China Cohort: First patient enrolled: 07 Apr 2015; last patient enrolled: 30 Oct 2015. 127 patients screened across 16 sites; 32 were randomized. Results are reported for analysis of PFS (DCO: 16 Jan 2017) and OS (DCO: 03 Feb 2020).

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Preserved source evidence · Not medical advice