A disproportionality analysis of adverse event reports for givinostat in the FDA adverse event reporting system (FAERS) database
Givinostat was recently approved for Duchenne muscular dystrophy (DMD), but its real-world safety profile remains incompletely characterized. We evaluated givinostat-associated safety signals by data mining of the FDA Adverse Event Reporting System (FAERS) database. Reporting Odds Ratio (ROR), Proportional...