Participant flow

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia · Source last updated 2021-05-18

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

groups

1. description

   Participants with Philadelphia chromosome-positive chronic myeloid leukemia (CML) received bosutinib tablets at a dose of 400 milligram (mg), orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

   id

   FG000

   title

   Bosutinib

2. description

   Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

   id

   FG001

   title

   Imatinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         12

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Investigator Request

   3. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      type

      Deceased

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         7

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Missing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         268

      2. group Id

         FG001

         num Subjects

         268

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         268

      2. group Id

         FG001

         num Subjects

         265

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         246

      2. group Id

         FG001

         num Subjects

         241

      type

      mITT Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         232

      2. group Id

         FG001

         num Subjects

         231

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         37

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice