Participant flow

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

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

groups

1. description

   Participants were randomized to sabatolimab plus Azacitidine

   id

   FG000

   title

   Sabatolimab (MBG453) + Azacitidine

2. description

   Participants were randomized to placebo plus Azacitidine

   id

   FG001

   title

   Placebo + Azacitidine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         111

      2. group Id

         FG001

         num Subjects

         92

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         43

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         35

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         22

      type

      Hematopoietic Stem-Cell Transplantation (HSCT) Planned

   5. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         27

      type

      Study Terminated by Sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         28

      type

      Participant Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         9

      type

      Physician Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      New Therapy for Study Indication

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Protocol Deviation

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Guardian Decision

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Lost to Follow-up

   12. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          1

       type

       Participants Not Treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         265

      2. group Id

         FG001

         num Subjects

         265

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         264

      2. group Id

         FG001

         num Subjects

         264

      type

      Participants Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participants Not treated

   4. achievements

      1. group Id

         FG000

         num Subjects

         264

      2. group Id

         FG001

         num Subjects

         264

      type

      Discontinued from treatment

   5. achievements

      1. group Id

         FG000

         num Subjects

         68

      2. group Id

         FG001

         num Subjects

         71

      type

      Entered post-treatment

   6. achievements

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         193

      type

      Did not enter post-treatment

   7. achievements

      1. group Id

         FG000

         num Subjects

         265

      2. group Id

         FG001

         num Subjects

         265

      type

      Discontinued from study

   8. achievements

      1. group Id

         FG000

         num Subjects

         265

      2. group Id

         FG001

         num Subjects

         265

      type

      Full Analysis See (FAS)

   9. achievements

      1. group Id

         FG000

         num Subjects

         263

      2. group Id

         FG001

         num Subjects

         265

      comment

      Two participants (one per arm) did not receive treatment and were excluded from the Safety Set. One sabatolimab-assigned participant withdrew consent pre-treatment. Another, randomized to placebo, progressed to AML before treatment and died. One sabatolimab-assigned participant progressed to AML, received only azacitidine, and was analyzed in the placebo Safety Set.

      type

      Safety Set

   10. achievements

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          0

       comment

       Completed = Completed treatment

       type

       COMPLETED

   11. achievements

       1. group Id

          FG000

          num Subjects

          265

       2. group Id

          FG001

          num Subjects

          265

       type

       NOT COMPLETED

   title

   Overall Study

recruitment Details

This study randomized participants in 149 centers in 36 participating countries.

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Preserved source evidence · Not medical advice