Medicine and Health Sciences Commons^™

Comparison Of Post-Marketing Surveillance Approaches Regarding Infections Related To Tumor Necrosis Factor (Tnf) Inhibitors, Cheng Chen

Pharmaceutical Sciences ETDs

Objective: Both spontaneous (voluntary) reporting systems and observational approaches serve as important tools in post-marketing surveillance for adverse drug events, however, each has its own advantages. The primary purpose of this project was to compare and contrast the FDA Adverse Event Reporting System (FAERS) data and findings from observational studies in post-marketing surveillance through examining TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab and golimumab) related infections, and secondarily, to examine the applicability of additional analyses in FAERS, such as multiple logistic regressions and time to onset of event analysis.

Methods: Using MedDRA^® preferred terms (PTs), infection and infestation cases in …