Participant flow

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer · Source last updated 2024-12-06

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

groups

1. description

   Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

   id

   FG000

   title

   Enzalutamide

2. description

   Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

   id

   FG001

   title

   Bicalutamide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         7

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         75

      2. group Id

         FG001

         num Subjects

         103

      type

      Progressive Disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         26

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         42

      type

      Miscellaneous Reason

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomized but never received study drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         184

      2. group Id

         FG001

         num Subjects

         191

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         183

      2. group Id

         FG001

         num Subjects

         189

      type

      Received Treatment

   3. achievements

      1. comment

         Indicates participants were still receiving treatment at the data cut-off date of 19 October 2014.

         group Id

         FG000

         num Subjects

         42

      2. comment

         Indicates participants were still receiving treatment at the data cut-off date of 19 October 2014.

         group Id

         FG001

         num Subjects

         9

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         182

      type

      NOT COMPLETED

   title

   Double-blind Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         3

      type

      Progressive disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      Miscellaneous Reason

   6. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         5

      type

      Transitioned to 9785-CL-0123 NCT02960022

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         9

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         9

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Open-label Period (All Enzalutamide)

pre Assignment Details

Participants were stratified by whether bilateral orchiectomy or receipt of luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy started before or after the diagnosis of metastases and by site.

recruitment Details

Men with metastatic castration-resistant prostate cancer (mCRPC) were enrolled at 84 sites in a total of 8 countries.

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Preserved source evidence · Not medical advice