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
†Infection includes bacterial, viral, fungal, and non-specified.
‡Includes infusion related reaction, injection site erythema, injection site hematoma, injection site hemorrhage, injection site hypersensitivity, injection site induration, injection site inflammation, injection site irritation, injection site mass, injection site edema, injection site pruritus, injection site rash, and injection site reaction.
Incidence of lab abnormalities
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