Participant flow

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18

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

groups

1. description

   Relugolix 120-milligram (mg) tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.

   id

   FG000

   title

   Relugolix

2. description

   Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.

   id

   FG001

   title

   Leuprolide Acetate

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         8

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         13

      type

      Testosterone Suppression Level Not Met

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Did not Receive Study Drug

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Dosing Interruption (Logistical Reason)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         624

      2. group Id

         FG001

         num Subjects

         310

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         622

      2. group Id

         FG001

         num Subjects

         308

      comment

      Four participants (2 in each treatment group) were randomized but did not receive study drug.

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         563

      2. group Id

         FG001

         num Subjects

         276

      comment

      Completed 48 weeks of treatment.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         34

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The primary analysis of efficacy and safety included 934 participants. The primary analysis excluded additional participants with metastatic disease and a cohort of participants enrolled in China and Taiwan who will be included in the final analysis of the study (N=200).

recruitment Details

To support registration in China, the study continued to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 90 participants.

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

Preserved source evidence · Not medical advice