Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase^®.

ABSTRACT:

Introduction

The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and VigiBase^® are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS).

Objective

Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA).

Methods

SDRs for 100 selected products were identified with two sets of thresholds (standard EudraVigilance SDR criteria for all vs Bayesian approach for FAERS and VigiBase^®). Per pr

SUBMITTER: Vogel U 

PROVIDER: S-EPMC7105447 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature