Real-World Safety of Nemolizumab: A Pharmacovigilance Analysis Using the FDA Adverse Event Reporting System (FAERS)

The Methodological Appendix describes the analytical framework for this pharmacovigilance study using spontaneous adverse event reports from the FDA Adverse Event Reporting System (FAERS). Adverse events were analyzed at the level of MedDRA Preferred Terms (PTs), with a standard 2×2 contingency table constructed for each PT of interest comparing nemolizumab versus all other drugs.