Participant flow

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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

groups

1. description

   Participants who were randomized to receive quizartinib treatment regimen.

   id

   FG000

   title

   Quizartinib

2. description

   Participants who were randomized to receive placebo treatment regimen.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         70

      type

      Refractory disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         65

      type

      Relapse

   3. reasons

      1. group Id

         FG000

         num Subjects

         58

      2. group Id

         FG001

         num Subjects

         23

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         23

      type

      Subject decision to stop study drug

   5. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         11

      type

      Other reasons not specified

   6. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         6

      type

      Non-protocol-specified AML therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         7

      type

      Investigator decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         12

      type

      Failure to meet continuation criteria

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Pregnancy

   11. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         268

      2. group Id

         FG001

         num Subjects

         271

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         265

      2. group Id

         FG001

         num Subjects

         268

      type

      Safety Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         56

      2. group Id

         FG001

         num Subjects

         52

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         212

      2. group Id

         FG001

         num Subjects

         219

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 539 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at 193 study sites in the following countries: Spain, Italy, Republic of Korea, Japan, China, US, France, Brazil, Germany, Russian Federation, Taiwan, Hungary, Czech Republic, Romania, Israel, Canada, Serbia, Poland, Portugal, Australia, Belgium, Bulgaria, Croatia, Ukraine, Singapore, and the UK. A total of 6 participants were randomized, but did not received treatment.

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

Preserved source evidence · Not medical advice