FAERS Query

A disproportionality analysis was conducted on the ADRs submitted to FAERS for a pool of 30 antipsychotics listed in Table ​Table1.1. The FAERS data were accessed by Empirica™ Signal, Oracle’s pharmacovigilance software (version 8.1.1, release 2020Q2; Oracle Inc., Redwood City, CA, USA). The FAERS data included all pre-1997 Spontaneous Reporting System (SRS) data, Adverse Event Reporting System data through August 2012, and FAERS data from August 2012 to June 2020. Generic and trade names were mapped in Empirica data within Oracle’s curated and updated drug name mapping algorithms, including handling of all trade names with more than one generic name. Duplicate reports (referring to the same drug-event pair appearing more than once) were excluded from data mining via Oracle’s automated duplicate detection algorithm that identifies duplicated reports based on a sufficient overlap of matching records, equivalence of demographic fields, and a combination of manufacturer, drug, and event information, including drug and/or event start dates. Preferred Terms for a pool of 30 antipsychotics [Table in the Electronic Supplementary Material (ESM)] were ranked by a disproportionality analysis in FAERS, using the Empirical Bayes Geometric Mean (EBGM). In this analysis, the EBGM is calculated across a pool of 30 antipsychotics. As the pool of 30 antipsychotics spanned launch years from 1951 to 2016, the influences of confounding factors, important for any individual drug and/or individual drug-event pairings (e.g., Weber effect, polypharmacy, indication, competition, and notoriety biases), on the estimate of relative risk ratio (RRR), were reduced. The confidence limits (from EBGM₀₅ to EBGM₉₅) for each PT were also estimated (Table in the ESM). Preferred Terms in the ulotaront and lurasidone clinical trial databases were re-coded to the latest PTs of the Medical Dictionary for Regulatory Activities (version 23.1) used by FAERS in Empirica at the time of the data analysis.

Pool of 30 antipsychotics and number of adverse drug reaction reports