Participant flow

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care · Source last updated 2019-10-29

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

groups

1. description

   Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.

   id

   FG000

   title

   Azacitidine

2. description

   Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)

   id

   FG001

   title

   Conventional Care

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         10

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         7

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         37

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         18

      type

      Lack of Efficacy

   7. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         20

      type

      Disease Progression

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Different Central+Local Pathology Review

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Not Documented

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         179

      2. comment

         Best supportive care: 105, Low-dose cytarabine: 49, Standard chemotherapy: 25 patients

         group Id

         FG001

         num Subjects

         179

      type

      STARTED

   2. achievements

      1. comment

         Includes those who died or transformed to AML, or receiving drug + eligible for extension period.

         group Id

         FG000

         num Subjects

         109

      2. comment

         Includes patients who died or transformed to AML during treatment, or were still receiving drug.

         group Id

         FG001

         num Subjects

         81

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         98

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

738 patients screened from 98 investigator sites. Randomized patients contributed by 79 investigator sites.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice