Participant flow

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16

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

groups

1. description

   Enrolled patients were randomized to 20mg pasireotide LAR.

   id

   FG000

   title

   Pasireotide LAR 20mg

2. description

   Enrolled patients were randomized to 40mg pasireotide LAR.

   id

   FG001

   title

   Pasireotide LAR 40mg

3. description

   Enrolled patients were randomized to 60mg pasireotide LAR.

   id

   FG002

   title

   Pasireotide LAR 60mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Unsatisfactory therapeutic effect

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Condition no longer requires study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Completed Core/did not enter Ext.

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         11

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         11

      type

      Entered/Treated in Core Phase

   3. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         10

      type

      Completed Core Phase

   4. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         9

      type

      Entered Ext. Phase

   5. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Did Not Enter Ext. Phase

   6. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         8

      type

      Treated Beyond 24 Months

   7. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         1

      type

      Discontinued Beyond 24 Months

   8. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         7

      type

      COMPLETED

   9. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

30 patients were planned and 33 patients were enrolled. The full analysis sets (FAS) consisted of 33 patients (11 patients per dose group).

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Preserved source evidence · Not medical advice