Participant flow

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy · Source last updated 2026-03-10

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

groups

1. description

   Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).

   id

   FG000

   title

   Placebo

2. description

   Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).

   id

   FG001

   title

   Niraparib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Site closed

   3. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         48

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         36

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         246

      2. group Id

         FG001

         num Subjects

         487

      type

      STARTED

   2. achievements

      1. comment

         2 participants never received treatment due to screen failure after randomization.

         group Id

         FG000

         num Subjects

         244

      2. comment

         3 participants never received treatment (2 failed screening \& 1 withdrew consent before first dose).

         group Id

         FG001

         num Subjects

         484

      type

      Received Study Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         177

      type

      Ongoing With Treatment in the Study

   4. achievements

      1. comment

         69 participants are ongoing in the study.

         group Id

         FG000

         num Subjects

         191

      2. comment

         177 participants are ongoing in the study.

         group Id

         FG001

         num Subjects

         397

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         90

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 989 participants were screened, of which 256 participants did not meet eligibility criteria. A total of 733 participants were enrolled and randomized in the study, of which 728 participants received study treatment (4 participants were screen failures after randomization and 1 participant withdrew consent before first dose).

recruitment Details

In this double-blind, randomized, placebo-controlled study, participants with stage III or IV ovarian cancer were randomized to receive either niraparib or placebo in 2:1 ratio. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).

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Preserved source evidence · Not medical advice