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A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system 期刊论文

编号：

C1C0AB3FC4F392A6885F0E12961BDA4C
作者：

Fang, Zhihong#^[1]Xu, Zhiqiang(许志强)#^[2]Zhu, Wei(朱伟)#^[2]Yu, Mingming(於明明)*^[3]Ji, Chunmei(季春梅)*^[2]
语种：

英文
期刊：

FRONTIERS IN PHARMACOLOGY ISSN：1663-9812 2023 年 14 卷 ; JUN 5
收录：
关键词：

apalutamide FDA adverse event reporting system disproportionality analyses adverse event real-world
摘要：

Background: Apalutamide is a new drug class, which is approved to treat prostate cancer (PCa). The aim of our study was to assess the safety profiles of apalutamide in real-world through data mining of the United States Food and Drug Administration Adverse Event Reporting System (FAERS).Method: We included adverse event (AE) reports regarding apalutamide submitted to the FAERS from 2018 quarter 1 (2018Q1) to 2022 quarter 1 (2022Q1). Disproportionality analyses, including reporting odds ratio (ROR), were performed to identify the signals of AEs in patients receiving apalutamide. A signal was detected if the lower limit of the 95% confidence interval (CI) of ROR >1 and at least 3 AEs were reported.Results: The FAERS database documented 4,156 reports regarding apalutamide from 1 January 2018, to 31 March 2022. A total of 100 significant disproportionality preferred terms (PTs) were retained. Frequently observed AEs in patients receiving apalutamide included rash, fatigue, diarrhea, hot flush, fall, weight decreased, hypertension. The most significant system organ class (SOC) was "skin and subcutaneous tissue disorders", which mainly consisted of dermatological adverse events (dAEs). The additional AEs observed with the significantly signal contain lichenoid keratosis, increased eosinophil count, bacterial pneumonia, pulmonary tuberculosis, hydronephrosis.Conclusion: Our findings provide valuable evidence for apalutamide safety profile in the real-world, which could help clinicians and pharmacists to enhance their vigilance and improve the safety of apalutamide in clinical practice.
推荐引用方式
GB/T 7714：

Fang Zhihong,Xu Zhiqiang,Zhu Wei, et al. A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system [J].FRONTIERS IN PHARMACOLOGY,2023,14.
APA：

Fang Zhihong,Xu Zhiqiang,Zhu Wei,Yu Mingming,&Ji Chunmei.(2023).A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system .FRONTIERS IN PHARMACOLOGY,14.
MLA：

Fang Zhihong, et al. "A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system" .FRONTIERS IN PHARMACOLOGY 14(2023).
入库时间：

8/19/2023 10:56:51 PM
更新时间：

8/19/2023 10:56:51 PM
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