Participant flow

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer · Source last updated 2012-12-19

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

groups

1. description

   Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.

   id

   FG000

   title

   Degarelix 240/160 mg

2. description

   Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.

   id

   FG001

   title

   Degarelix 240/80 mg

3. description

   Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

   id

   FG002

   title

   Leuprolide 7.5 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         12

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         2

      type

      Taking prohibited therapy

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      type

      Administrative errors

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Trial drug errors

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Disease progression

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Personal reasons

   9. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      type

      Randomized but never received trial drug

   10. reasons

       1. group Id

          FG000

          num Subjects

          9

       2. group Id

          FG001

          num Subjects

          4

       3. group Id

          FG002

          num Subjects

          7

       type

       Withdrawal by Subject

   11. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          4

       3. group Id

          FG002

          num Subjects

          2

       type

       Protocol Violation

   milestones

   1. achievements

      1. comment

         randomized

         group Id

         FG000

         num Subjects

         206

      2. comment

         randomized

         group Id

         FG001

         num Subjects

         210

      3. comment

         randomized

         group Id

         FG002

         num Subjects

         204

      type

      STARTED

   2. achievements

      1. comment

         randomized and exposed patients

         group Id

         FG000

         num Subjects

         202

      2. comment

         randomized and exposed patients

         group Id

         FG001

         num Subjects

         207

      3. comment

         randomized and exposed patients

         group Id

         FG002

         num Subjects

         201

      type

      Intent-to-treat (ITT) Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         163

      2. group Id

         FG001

         num Subjects

         169

      3. group Id

         FG002

         num Subjects

         172

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         32

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice