The Double FDR method of Mehrotra and Heyse (2004) is used to compare the incidence of adverse events among treatments, leveraging the grouping of related adverse events (typically defined by the MedDRA system organ class). The method considers whether related terms within a group show differences between the treatments and upweights or downweights the significance of an individual term within the group accordingly. In the 2004 paper, the FDR adjustment is performed twice, and simulations are used to control the false discovery rate. Mehrotra and Adewale (2011) refine the Double FDR method to avoid the need for simulations by applying FDR adjustment thrice.