Disproportionality Analysis and its Application to Spontaneously-Reported Adverse Events in Pharmacovigilance

Spontaneously-reported adverse events are collected to monitor the safety of drugs once they reach the market. Analyzing these data require techniques that are distinct from those used in the analysis of adverse events from clinical trials. Richard Zink discusses these differences, describes common methods to measure disproportionality and illustrates these techniques using JMP Clinical.