Safety was evaluated across 3 clinical trials
Safety data were drawn from 163 adult patients with TKI-resistant and/or -intolerant
chronic phase or accelerated phase CML
Adverse reactions, including those leading to discontinuation
Adverse reactions were reported for 99% of chronic phase patients and 100%
of accelerated phase patients
18% of chronic phase patients and 33% of accelerated phase patients had
adverse reactions leading to withdrawal. The following are those reported most frequently
- Chronic phase: pancytopenia, thrombocytopenia, and increased alanine aminotransferase
(each 2%)
- Accelerated phase: leukocytosis (6%) and thrombocytopenia (4%)
Serious adverse reactions were reported for 51% of chronic phase patients and
60% of accelerated phase patients. The following are those reported for at least
5% of patients
- Chronic phase: bone marrow failure and thrombocytopenia (each 10%), infections
(8%), and febrile neutropenia (6%)
- Accelerated phase: febrile neutropenia (18%), infections (11%), thrombocytopenia
(9%), anemia (7%), and diarrhea (6%)
Incidence of adverse reactions
Incidence of lab abnormalities