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Abstract Objective: Alectinib is the standard first-line therapy for treatment-naïve ALK-positive non-small cell lung cancer (NSCLC). Given its increasing clinical utilization, a comprehensive pharmacovigilance evaluation of its adverse events (AEs) is warranted. Methods: We assessed alectinib-associated AEs using the FDA Adverse Event Reporting System (FAERS) database from Q4 2015 to Q3 2025.
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