Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Expert opinion on drug safety - (2024) vom: 22. Jan., Seite 1-8 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kim, Jae Hyun [VerfasserIn] |
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| Links: |
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| Themen: |
Administrative claims, healthcare |
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| Anmerkungen: |
Date Revised 25.01.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1080/14740338.2024.2309223 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367423618 |
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| 100 | 1 | |a Kim, Jae Hyun |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events |
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| 500 | |a Date Revised 25.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Drug-related side effects and adverse reactions | |
| 650 | 4 | |a Pharmacoepidemiology | |
| 650 | 4 | |a Pharmacovigilance | |
| 650 | 4 | |a administrative claims, healthcare | |
| 650 | 4 | |a late onset disorders | |
| 700 | 1 | |a Song, Yun-Kyoung |e verfasserin |4 aut | |
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