دورية أكاديمية
A real-world disproportionality analysis of Tivozanib data mining of the public version of FDA adverse event reporting system
| العنوان: | A real-world disproportionality analysis of Tivozanib data mining of the public version of FDA adverse event reporting system |
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| المؤلفون: | Kaixuan Wang, Mengmeng Wang, Wensheng Li, Xiaohui Wang |
| المصدر: | Frontiers in Pharmacology, Vol 15 (2024) |
| بيانات النشر: | Frontiers Media S.A., 2024. |
| سنة النشر: | 2024 |
| المجموعة: | LCC:Therapeutics. Pharmacology |
| مصطلحات موضوعية: | FAERS, Tivozanib, adverse events, ccRCC, adverse drug reactions, Therapeutics. Pharmacology, RM1-950 |
| الوصف: | BackgroundTivozanib, a vascular endothelial growth factor tyrosine kinase inhibitor, has demonstrated efficacy in a phase III clinical trials for the treatment of renal cell carcinoma. However, comprehensive evaluation of its long-term safety profile in a large sample population remains elusive. The current study assessed Tivozanib-related adverse events of real-world through data mining of the US Food and Drug Administration Adverse Event Reporting System FDA Adverse Event Reporting System.MethodsDisproportionality analyses, utilizing reporting odds ratio proportional reporting ratio Bayesian confidence propagation neural network and multi-item gamma Poisson shrinker (MGPS) algorithms, were conducted to quantify signals of Tivozanib-related AEs. Weibull distribution was used to predict the varying risk incidence of AEs over time.ResultsOut of 5,361,420 reports collected from the FAERS database, 1,366 reports of Tivozanib-associated AEs were identified. A total of 94 significant disproportionality preferred terms (PTs) conforming to the four algorithms simultaneously were retained. The most common AEs included fatigue, diarrhea, nausea, blood pressure increased, decreased appetite, and dysphonia, consistent with prior specifications and clinical trials. Unexpected significant AEs such as dyspnea, constipation, pain in extremity, stomatitis, and palmar-plantar erythrodysaesthesia syndrome was observed. The median onset time of Tivozanib-related AEs was 37 days (interquartile range [IQR] 11.75–91 days), with a majority (n = 127, 46.35%) occurring within the initial month following Tivozanib initiation.ConclusionOur observations align with clinical assertions regarding Tivozanib’s safety profile. Additionally, we unveil potential novel and unexpected AE signatures associated with Tivozanib administration, highlighting the imperative for prospective clinical studies to validate these findings and elucidate their causal relationships. These results furnish valuable evidence to steer future clinical inquiries aimed at elucidating the safety profile of Tivozanib. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1663-9812 95896325 |
| Relation: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1408135/full; https://doaj.org/toc/1663-9812 |
| DOI: | 10.3389/fphar.2024.1408135 |
| URL الوصول: | https://doaj.org/article/286fd9f3143c423c9c9589632516fe4d |
| رقم الأكسشن: | edsdoj.286fd9f3143c423c9c9589632516fe4d |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 16639812 95896325 |
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| DOI: | 10.3389/fphar.2024.1408135 |