Participant flow

Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only · Source last updated 2014-02-11

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

groups

1. description

   This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.

   id

   FG000

   title

   Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W

2. description

   This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.

   id

   FG001

   title

   Denosumab 120 mg Q4W / Denosumab 120 mg Q4W

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Consent withdrawn

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Administrative decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Ineligibility determined

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Noncompliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor performance status

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         18

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         15

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Subjects recuited in this open-label extension study were those who were enrolled in the 2 parent (phase 3, randomized, double-blind, active-controlled) studies 20050103 (NCT00321620) or 20050136 (NCT00321464) at sites in the Czech Republic and United Kingdom.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice