Participant flow

Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab · Source last updated 2017-03-15

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

groups

1. description

   Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma

   id

   FG000

   title

   Denosumab 120 mg Q4W - Plateau-Phase

2. description

   Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma

   id

   FG001

   title

   Denosumab 120 mg Q4W - Relapsed

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         36

      type

      Disease progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         3

      type

      Ongoing

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Requirement for alternative therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         53

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         53

      type

      Received Study Medication

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         53

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were enrolled from 13 February 2006 through 8 December 2006

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

Preserved source evidence · Not medical advice