Participant flow

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer · Source last updated 2019-01-30

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 milligram (mg), self-administered as four 40-mg capsules, and 1 bicalutamide matching placebo capsule once per day, by mouth for up to 29 months in double blind (DB) phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules once per day by mouth for up to 36 months in open label phase.

   id

   FG000

   title

   Enzalutamide

2. description

   Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide matching placebo capsules for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth for up to 36 months in open label phase.

   id

   FG001

   title

   Bicalutamide Then Enzalutamide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         65

      2. group Id

         FG001

         num Subjects

         132

      type

      Disease Progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         9

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Randomized, But Not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         198

      2. group Id

         FG001

         num Subjects

         198

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         197

      2. group Id

         FG001

         num Subjects

         198

      type

      Received Study Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         93

      2. group Id

         FG001

         num Subjects

         38

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         105

      2. group Id

         FG001

         num Subjects

         160

      type

      NOT COMPLETED

   title

   Period1:Double Blind Phase-29 Months

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      On Treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         9

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         93

      2. group Id

         FG001

         num Subjects

         38

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         93

      2. group Id

         FG001

         num Subjects

         37

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         15

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Period 2: Open-label Phase-36 Months

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Preserved source evidence · Not medical advice