gtreg internally leverages gtsummary to streamline production for regulatory tables in clinical research. There are three functions to assist with adverse event reporting tbl_ae_count(), tbl_ae(), and tbl_ae_focus(); tbl_ae_count() tabulates all AEs observed, whereas both tbl_ae() and tbl_ae_focus() count a single AE per subject by maximum grade. Furthermore, tbl_reg_summary() produces standard data summary tables often used in regulatory submissions and ‘tbl_listing()’ enables a formatted grouped printing of raw AE listings. All functions are highly customizable to make your regulatory reporting a breeze!