Participant flow

A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. · Source last updated 2022-11-08

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 subcutaneous denosumab placebo once every 4 weeks

   id

   FG000

   title

   Zoledronic Acid

2. description

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

   id

   FG001

   title

   Denosumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         169

      2. group Id

         FG001

         num Subjects

         174

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         124

      2. group Id

         FG001

         num Subjects

         124

      type

      Disease progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         117

      2. group Id

         FG001

         num Subjects

         118

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         61

      type

      Participant request

   5. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         28

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         14

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         10

      type

      Noncompliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         8

      type

      Lost to Follow-up

   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

          21

       2. group Id

          FG001

          num Subjects

          18

       type

       Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1020

      2. group Id

         FG001

         num Subjects

         1026

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1014

      2. group Id

         FG001

         num Subjects

         1019

      type

      Received Investigational Product

   3. achievements

      1. group Id

         FG000

         num Subjects

         461

      2. group Id

         FG001

         num Subjects

         468

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         559

      2. group Id

         FG001

         num Subjects

         558

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

2049 patients were enrolled in the study, but 3 patients were excluded from all analyses because properly documented informed consent was not obtained.

recruitment Details

Participants were enrolled from 27 April 2006 through 31 December 2007

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

Preserved source evidence · Not medical advice