Participant flow

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 · Source last updated 2024-05-20

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

groups

1. description

   Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg every 4 weeks \[Q4W\] subcutaneous injection \[SC\]) and schedule at the investigator's discretion.

   id

   FG000

   title

   Exposed to Investigational Product (IP)

2. description

   Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.

   id

   FG001

   title

   Not Exposed to IP

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Decision by Sponsor

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         51

      2. group Id

         FG001

         num Subjects

         34

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         51

      2. group Id

         FG001

         num Subjects

         0

      type

      Received Denosumab

   3. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         26

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         8

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants in the study were enrolled upon completing study 20062004.

recruitment Details

Participants with giant cell tumor of bone (GCTB) were enrolled across 8 countries (Australia, Italy, France, Poland, Spain, Sweden, the United Kingdom of Great Britain and Northern Ireland, and the United States) between November 2017 and July 2023.

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Preserved source evidence · Not medical advice