Participant flow

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma · Source last updated 2020-02-26

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

groups

1. description

   Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX

   id

   FG000

   title

   Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone

2. description

   Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX

   id

   FG001

   title

   Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Radiological progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Clinical progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      AE not related to clinical progression

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

10 participants were screened in the study; 4 participants in Cohort 1 and 6 participants in Cohort 2. 3 of these participants failed screening procedures, all for the reason "inclusion criteria not met". No participants were started in the Phase 2 part of the study prior to study termination.

recruitment Details

The study was conducted in 7 study centers, the first participant first visit was on 10/Feb/2017 and last participant last visit on 20/Mar/2019

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

Preserved source evidence · Not medical advice