Participant flow

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies · Source last updated 2021-06-29

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

groups

1. description

   Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

   id

   FG000

   title

   CML-CP With Prior Imatinib Only

2. description

   Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

   id

   FG001

   title

   CML-AP With Prior Imatinib Only

3. description

   Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).

   id

   FG002

   title

   CML-CP

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         215

      2. group Id

         FG001

         num Subjects

         122

      3. group Id

         FG002

         num Subjects

         34

      type

      Discontinued in core study without entering the extension study

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Abnormal laboratory values

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Administrative problems

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         3

      type

      Disease progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   9. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Patient withdrew consent

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         321

      2. group Id

         FG001

         num Subjects

         137

      3. group Id

         FG002

         num Subjects

         49

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         106

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         15

      type

      Entered Extension Study

   3. achievements

      1. group Id

         FG000

         num Subjects

         67

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         8

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         254

      2. group Id

         FG001

         num Subjects

         129

      3. group Id

         FG002

         num Subjects

         41

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 507 participants were randomized in the core study, out of which 136 participants entered the extension study.

recruitment Details

The study was conducted at 100 centers in 22 countries.

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

Preserved source evidence · Not medical advice