Adverse reactions of second-line tyrosine kinase inhibitors in advanced hepatocellular carcinoma treatment: a descriptive analysis from WHO-VigiAccess

Background: Given the increasing use of targeted therapies in clinical practice, we aimed to determine the clinically actionable safety profiles of second-line tyrosine kinase inhibitors (TKIs) in advanced hepatocellular carcinoma (HCC) by analysing adverse drug reactions (ADRs) reported in the WHO-VigiAccess database. Methods: Retrospective descriptive analysis of ADR reports for cabozantinib and regorafenib in advanced HCC after first-line failure. Data included patient demographics, geographic distribution, system organ classes (SOCs) and preferred terms (PTs) (MedDRA v24.0). Chi-squared tests were used to compare patient characteristics; head-to-head disproportionality analysis [reporting odds ratio (ROR)] was performed for gastrointestinal (GI) disorders. Results: 60.3%; P