Participant flow

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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

groups

1. description

   CC-5013 (lenalidomide) plus oral high-dose dexamethasone

   id

   FG000

   title

   CC-5013/Dex

2. description

   Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

   id

   FG001

   title

   Placebo/Dex

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         18

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         124

      type

      Progression of disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         177

      2. group Id

         FG001

         num Subjects

         176

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         64

      2. group Id

         FG001

         num Subjects

         13

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         113

      2. group Id

         FG001

         num Subjects

         163

      type

      NOT COMPLETED

   title

   Up to Unblinding (07 Jun 2005)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         87

      2. group Id

         FG001

         num Subjects

         0

      type

      Progression of disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         177

      2. group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         171

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Extended Follow-up Cutoff (23 Jul 2008)

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Transferred into expanded access study.

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Transferred into RevAssist Program

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      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

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Final Follow-up

pre Assignment Details

Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)". Data for the period "Extended Follow-up Cutoff (23 Jul 2008)" subsumes data for the period "Up To Unblinding (07 Jun 2005)".

recruitment Details

Subjects in the Placebo/Dex treatment group did not continue participation beyond the period "Up To Unblinding (07 Jun 2005"). Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)".

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

Preserved source evidence · Not medical advice