Participant flow

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. · Source last updated 2018-06-19

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

groups

1. description

   Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.

   id

   FG000

   title

   Pasireotide 600 μg

2. description

   Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day

   id

   FG001

   title

   Pasireotide 900 μg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         23

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         8

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Abnormal laboratory value(s)

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      condition no longer requires study drug

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         55

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         19

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         36

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

After a 21-day screening period, patients who met the inclusion/exclusion criteria received pasireotide subcutaneous twice a day (BID)

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Preserved source evidence · Not medical advice