Participant flow

EXTEND (Eltrombopag Extended Dosing Study) · Source last updated 2017-04-17

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

groups

1. description

   Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

   id

   FG000

   title

   Eltrombopag

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         42

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         39

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         39

      type

      Various -follow up w clinical team

   4. reasons

      1. group Id

         FG000

         num Subjects

         32

      type

      Lack of Efficacy

   5. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Non-compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         302

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         51

      type

      Subjects From TRA100773A

   3. achievements

      1. group Id

         FG000

         num Subjects

         61

      type

      Subjects From TRA100773B

   4. achievements

      1. group Id

         FG000

         num Subjects

         146

      type

      Subjects From TRA102537 Raise

   5. achievements

      1. group Id

         FG000

         num Subjects

         43

      type

      Subjects From TRA108057 Repeat

   6. achievements

      1. comment

         Mistakenly enrolled (not in any of the 3 trials) On 50 mg/d eltrombopag for 18 days and withdrawn

         group Id

         FG000

         num Subjects

         1

      type

      Unknown - Not From Previous Trial

   7. achievements

      1. group Id

         FG000

         num Subjects

         135

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         167

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Subjects were previously enrolled in a study of eltrombopag: TRA100773A, TRA100773B, TRA102537/RAISE, or TRA108057/REPEAT. Eligibility of consenting subjects was assessed during the screening period of up to 28 days prior to Day 1 of treatment.

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Preserved source evidence · Not medical advice