Fig. 1

A flowchart illustrating the entire study, encompassing the following key aspects: data collection and cleaning processes for the two cohorts (FAERS and JADER), the methods of disproportionality analysis, and the critical components of the study. FAERS, FDA Adverse Event Reporting System; JADER, Japanese Adverse Drug Event Report; Q2, the second quarter; PT, preferred term; PS, primary suspect; SOC, system organ class; PT, preferred term