Participant flow

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2022-09-30

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

groups

1. description

   Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

   id

   FG000

   title

   E-Ld Cohort

2. description

   Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

   id

   FG001

   title

   Ld Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      No longer meeting study criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant request to discontinue

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse event unrelated to study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Consent withdrawal

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         374

      2. group Id

         FG001

         num Subjects

         374

      comment

      Started = randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         371

      2. group Id

         FG001

         num Subjects

         371

      comment

      Completed = continued to the treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Pre-treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         117

      2. group Id

         FG001

         num Subjects

         145

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         110

      2. group Id

         FG001

         num Subjects

         73

      type

      Adverse event unrelated to study drug

   3. reasons

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         64

      type

      Study drug toxicity

   4. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         22

      type

      Participant request to discontinue

   5. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         30

      type

      Other reasons

   6. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         7

      type

      Consent withdrawal

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      Poor/Non-compliance

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          1

       type

       Maximum clinical benefit

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          1

       type

       No longer meet study criteria

   12. reasons

       1. group Id

          FG000

          num Subjects

          8

       2. group Id

          FG001

          num Subjects

          16

       type

       Administrative reasons by Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         371

      2. group Id

         FG001

         num Subjects

         371

      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

         371

      2. group Id

         FG001

         num Subjects

         371

      type

      NOT COMPLETED

   title

   Treatment Period

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Preserved source evidence · Not medical advice