Participant flow

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma. · Source last updated 2019-04-26

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

groups

1. description

   All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks

   id

   FG000

   title

   Pasireotide LAR

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Acute or progressive vision loss

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Uncontrolled diabetes mellitus

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      abnormal laboratory values

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         20

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         20

      comment

      received at least 1 dose of study medication

      type

      Full Analysis Set (FAS)

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      comment

      rec'd at least 1 dose of drug + 1 at least one post-BL safety assessment

      type

      Safety Analysis Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         13

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Main Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Administrative problems

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         13

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         13

      comment

      received at least 1 dose of study drug

      type

      Full Analysis Set (FAS)

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      comment

      rec'd at least 1 dose of drug + 1 at least one post-BL safety assessment

      type

      Safety Analysis Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         10

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Extension Phase

pre Assignment Details

Twenty seven patients were screened and 21 met eligibility requirements.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice