Participant flow

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer · Source last updated 2018-08-29

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

groups

1. description

   Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks

   id

   FG000

   title

   Zoledronic Acid

2. description

   Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks

   id

   FG001

   title

   Denosumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         269

      2. group Id

         FG001

         num Subjects

         294

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         164

      2. group Id

         FG001

         num Subjects

         147

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         113

      2. group Id

         FG001

         num Subjects

         117

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         56

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         9

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         7

      type

      Noncompliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Protocol deviation

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Ineligibility determined

   10. reasons

       1. group Id

          FG000

          num Subjects

          75

       2. group Id

          FG001

          num Subjects

          52

       type

       Participant request

   11. reasons

       1. group Id

          FG000

          num Subjects

          42

       2. group Id

          FG001

          num Subjects

          33

       type

       Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         951

      2. group Id

         FG001

         num Subjects

         950

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         946

      2. group Id

         FG001

         num Subjects

         942

      type

      Received Investigational Product

   3. achievements

      1. group Id

         FG000

         num Subjects

         208

      2. group Id

         FG001

         num Subjects

         228

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         743

      2. group Id

         FG001

         num Subjects

         722

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

1904 participants were enrolled, however 3 were excluded from all analyses as Institutional Review Board review activities and oversight were not ensured.

recruitment Details

Participants were enrolled from 12 May 2006 through 18 December 2008.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice