Participant flow

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

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

groups

1. description

   Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

   id

   FG000

   title

   Luspatercept

2. description

   Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

   id

   FG001

   title

   Epoetin Alfa

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         181

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         179

      comment

      Continuing to Treatment Period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Randomization

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      type

      Other Reasons

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Study Terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         18

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         68

      type

      Lack of Efficacy

   8. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         7

      type

      Disease Progression

   9. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         5

      type

      Adverse Event

   10. reasons

       1. group Id

          FG000

          num Subjects

          14

       2. group Id

          FG001

          num Subjects

          13

       type

       Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         179

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         53

      comment

      Continuing in the Treatment Period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         126

      type

      NOT COMPLETED

   title

   Treatment

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Preserved source evidence · Not medical advice