Participant flow

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma. · Source last updated 2022-11-07

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 by subcutaneous injection 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

         316

      2. group Id

         FG001

         num Subjects

         310

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         126

      type

      Disease progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         143

      2. group Id

         FG001

         num Subjects

         124

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         36

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         22

      type

      Participant request

   6. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         22

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         17

      type

      Noncompliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol deviation

   10. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          1

       type

       Ineligibility determined

   11. reasons

       1. group Id

          FG000

          num Subjects

          36

       2. group Id

          FG001

          num Subjects

          44

       type

       Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         890

      2. group Id

         FG001

         num Subjects

         886

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         878

      2. group Id

         FG001

         num Subjects

         878

      type

      Received Investigational Product

   3. achievements

      1. group Id

         FG000

         num Subjects

         178

      2. group Id

         FG001

         num Subjects

         180

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         712

      2. group Id

         FG001

         num Subjects

         706

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 1779 participants were enrolled in the study. Three participants from one site were excluded from all analyses because Institutional Review Board (IRB) review activities and oversight were not ensured.

recruitment Details

Participants were enrolled from 21 June 2006 through 16 May 2008

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

Preserved source evidence · Not medical advice