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Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease · Source last updated 2020-09-18

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

groups

1. description

   Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension

   id

   FG000

   title

   All Patients

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Unsatisfactory therapeutic effect

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Abnormal lab value

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         68

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         52

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         16

      type

      NOT COMPLETED

   title

   Core Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Unsatisfactory therapeutic effect

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         29

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         12

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Extension Phase

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Preserved source evidence · Not medical advice