Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events.
| Autor: | Kim JH; School of Pharmacy and Institute of New Drug Development, Jeonbuk National University, Jeonju Republic of Korea., Song YK; College of Pharmacy, Daegu Catholic University, Gyeongbuk Republic of Korea. |
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| Jazyk: | angličtina |
| Zdroj: | Expert opinion on drug safety [Expert Opin Drug Saf] 2024 Sep; Vol. 23 (9), pp. 1183-1190. Date of Electronic Publication: 2024 Jan 25. |
| DOI: | 10.1080/14740338.2024.2309223 |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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