1. Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events.
- Author
-
Kim JH and Song YK
- Subjects
- Humans, Republic of Korea epidemiology, Time Factors, United States, United States Food and Drug Administration, Middle Aged, Pharmacovigilance, Male, Female, Adult, Tumor Necrosis Factor-alpha antagonists & inhibitors, Aged, Adverse Drug Reaction Reporting Systems statistics & numerical data, Drug-Related Side Effects and Adverse Reactions epidemiology, Databases, Factual
- Abstract
Objectives: Through the use of FDA adverse event reporting system (FAERS) dataset, this study analyzes the pattern of time-to-event (TTE) for drugs and adverse events, and suggest ways to identify candidate late-onset events for monitoring., Methods: The duration between administration date of the drug and the onset of adverse events was explored with using FAERS data from 2012-2021. The fold change of proportional reporting ratios or reporting odds ratios were calculated to identify enriched events in the later period and to suggest the late-onset events for further monitoring. To compare the findings, we used the claims database of the Korean National Health Insurance Service (NHIS)., Results: A total of 1,426,781 reports were included. The median TTE was 10 days (interquartile range [IQR]: 0-98 days), with 11.5% ( n = 164,093) reporting events that occurred at least one year after administration. TTE and fold change analysis captured historical cases of late-onset events, while generating an additional less-explored list of events. The results for tumor necrosis factor (TNF) inhibitors were compared using the NHIS dataset., Conclusion: Our study provides a comprehensive analysis of the FAERS dataset, focusing on TTE data. Periodic summarization of reports would be helpful in monitoring the late-onset events.
- Published
- 2024
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