Participant flow

A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia · Source last updated 2017-02-15

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

groups

1. description

   Tablets, oral, dasatinib 100 mg once daily (QD)

   id

   FG000

   title

   Dasatinib

2. description

   Tablets, oral, imatinib 400mg once daily (QD)

   id

   FG001

   title

   Imatinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         22

      type

      Disease progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         17

      type

      Intolerance

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         14

      type

      Treatment failure

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         4

      type

      AE unrelated to study drug

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Pregnancy

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         7

      type

      Poor compliance/noncompliance

   10. reasons

       1. group Id

          FG000

          num Subjects

          157

       2. group Id

          FG001

          num Subjects

          162

       type

       Administrative reason by sponsor

   11. reasons

       1. group Id

          FG000

          num Subjects

          6

       2. group Id

          FG001

          num Subjects

          15

       type

       Varied

   12. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          2

       type

       Did not receive treatment

   milestones

   1. achievements

      1. comment

         Randomized

         group Id

         FG000

         num Subjects

         259

      2. comment

         Randomized

         group Id

         FG001

         num Subjects

         260

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         258

      2. group Id

         FG001

         num Subjects

         258

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         259

      2. group Id

         FG001

         num Subjects

         260

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 547 patients enrolled, 519 were randomized and 516 received treatment. Of the 28 who were enrolled but not randomized, 20 no longer met study criteria, 3 withdrew consent, 1 was lost to follow-up, and 4 withdrew for other reasons.

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

Preserved source evidence · Not medical advice