Safety Profile and Adverse Event Management

In AML, frequent adverse reactions (≥25%) include leukopenia, diarrhea, hypokalemia, and QTc prolongation. Differentiation syndrome occurred in 15–25% of AML/MDS patients. For MDS, elevated creatinine (95%), arthralgia (42%), and fatigue (37%) were prominent. Cholangiocarcinoma patients reported fatigue (43%), nausea (41%), and ascites (23%). Serious reactions include tumor lysis syndrome, Guillain-Barré syndrome (0.8%), and fatal differentiation syndrome (3%). Lab abnormalities (e.g., AST elevation, hyperbilirubinemia) necessitate regular monitoring. Dose interruptions/reductions are guided by CTCAE grading, with permanent discontinuation for recurrent Grade 4 toxicities or neurologic deficits.