Participant flow

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) · Source last updated 2016-02-03

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

groups

1. description

   Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m\^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.

   id

   FG000

   title

   Everolimus

2. description

   Participants received oral dose of placebo matching to everolimus daily.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Administrative problems

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         39

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         33

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Core Period (48 Weeks)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      type

      Administrative problems

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Disease progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      New treatment for indication under study

   milestones

   1. achievements

      1. comment

         Of 117 participants only 111 completed the core period and continued in the extension period

         group Id

         FG000

         num Subjects

         111

      2. comment

         No participant received placebo.

         group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         82

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Open-label Extension Period (4 Years)

pre Assignment Details

A total of 117 participants were enrolled and randomized into the core period. Only 111 participants completing the core period, continued in the open-label extension period of the study.

recruitment Details

The study was conducted at 24 centers in 10 countries.

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Preserved source evidence · Not medical advice