Participant flow

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.

groups

1. description

   Taken orally twice daily

   id

   FG000

   title

   Olaparib 300mg Tablets

2. description

   Taken orally twice daily

   id

   FG001

   title

   Placebo Tablets

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Severe non-compliance to protocol

   2. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         26

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         260

      2. group Id

         FG001

         num Subjects

         131

      comment

      (Randomised to study treatment)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         183

      2. group Id

         FG001

         num Subjects

         91

      comment

      (Ongoing study at time of PFS analysis DCO:17 May 2018)

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         77

      2. group Id

         FG001

         num Subjects

         40

      type

      NOT COMPLETED

   title

   Overall Study (Global Cohort)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         20

      comment

      (Randomised to study treatment)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         14

      comment

      (Ongoing study at time of PFS analysis DCO:17 May 2018)

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study (China Cohort)

pre Assignment Details

It was planned that approximately 344 women in the Global Cohort, and 53 women in the China Cohort, with BRCA mutated ovarian cancer patients who are in clinical complete or partial response following first line platinum based chemotherapy were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.

recruitment Details

Global Cohort: 391 randomised. First/Last patient randomised 03Sep2013/06Mar2015. China Cohort: 64 randomised. First/Last patient randomised 09Jan2015/22Mar2016. A total of 450 patients randomised (386 global cohort only, 64 China cohort (of which 5 included in global cohort)). Global Cohort used for hypotheses testing of study.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice