Participant flow

Velcade Consolidation Bone Study · Source last updated 2016-05-30

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

groups

1. description

   bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

   id

   FG000

   title

   Bortezomib

2. description

   no treatment, observation only

   id

   FG001

   title

   Non-treated Control

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Intercurrent illness

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliance

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      The subject starts with alternative MMY

   8. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Patient's decision to stop treatment

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Progression of disease

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       refill medication not received in time

   milestones

   1. achievements

      1. comment

         One patient did not start treatment and was excluded from the Intent to Treat (ITT) population.

         group Id

         FG000

         num Subjects

         51

      2. comment

         One patient did not have any post-baseline assessment and was excluded from the ITT population.

         group Id

         FG001

         num Subjects

         53

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         46

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice