Participant flow

Study of Vimseltinib for Tenosynovial Giant Cell Tumor · Source last updated 2026-03-20

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

groups

1. description

   Participants received blinded treatment of vimseltinib 30 milligrams (mg) twice a week (BIW) for 24 weeks in Part 1 and open-label vimseltinib 30 mg BIW in Part 2 until end of treatment (EoT).

   id

   FG000

   title

   Part 1/Part 2: Vimseltinib/Vimseltinib

2. description

   Participants received blinded treatment of matching placebo BIW for 24 weeks in Part 1 and open-label vimseltinib 30 mg BIW in Part 2 until EoT.

   id

   FG001

   title

   Part 1/Part 2: Placebo/Vimseltinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Subsequent TGCT therapy and/or surgery

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Other reasons

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Ongoing in study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         83

      2. group Id

         FG001

         num Subjects

         40

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         83

      2. group Id

         FG001

         num Subjects

         39

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         75

      2. group Id

         FG001

         num Subjects

         35

      comment

      One participant was continuing in Part 1 of study at time of primary endpoint analysis.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         5

      type

      NOT COMPLETED

   title

   Part 1: Double Blind (Weeks 1 - 24)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         32

      type

      Ongoing in study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         35

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         35

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         35

      type

      NOT COMPLETED

   title

   Part 2: Open Label (Weeks 25 - EoS)

pre Assignment Details

Presented here is data from the Week 25 primary endpoint analysis. The study is ongoing.

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Preserved source evidence · Not medical advice