Mining and analysis of adverse event signals of vandetanib based on the FAERS database.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-22 DOI:10.1080/14740338.2024.2418326
Ying Zhou, Na Li, Guowei Ma, Ning Su, Jiang Liu, Wenxi Yue, Rui Yin, Jie Chen
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引用次数: 0

Abstract

Objective: By analyzing the signal mining of vandetanib AEs, it provides a reference for the rational clinical use of the drug.

Methods: This study provides signal detection and analysis of AEs associated with vandetanib using the FAERS from Q2 2011 to Q1 2023.

Results: Disproportionality analyses were conducted using the ROR and the MHRA method, with AEs categorized and described based on SOC and PT from the MedDRA. A total of 1,721 AEs reports identified vandetanib as the primary suspect. The analyses yielded 187 AEs signals across 20 SOCs categories, with 47 signals not previously reported in the vandetanib labeling. Additionally, the study analyzes factors influencing AEs. The results are as follows: There are significant differences in Investigations based on gender and nationality (p < 0.05); skin and subcutaneous tissue disorders and gastrointestinal disorders exhibit differences based on gender, age, and nationality (p < 0.05).

Conclusion: Common AEs signals identified align with those documented in the drug labeling. However, AEs such as tumor lysis syndrome, skin discoloration, and pigmentary disorders, which are not listed in the labeling, warrant special attention. It is essential that abnormalities in patients' skin and laboratory indicators are closely monitored and addressed promptly to safeguard medication safety.

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基于 FAERS 数据库挖掘和分析凡德他尼的不良事件信号。
目的:通过分析凡德他尼AEs的信号挖掘,为临床合理用药提供参考:通过对凡德他尼AEs的信号挖掘分析,为临床合理用药提供参考:本研究利用FAERS对2011年第二季度至2023年第一季度与凡德他尼相关的AE进行信号检测和分析:使用 ROR 和 MHRA 方法进行了比例失调分析,根据 MedDRA 中的 SOC 和 PT 对 AE 进行了分类和描述。共有1,721份AEs报告确定凡德他尼为主要疑似药物。分析得出了 187 个 AEs 信号,涉及 20 个 SOCs 类别,其中 47 个信号以前未在凡德他尼标签中报告过。此外,研究还分析了影响 AEs 的因素。结果如下基于性别和国籍的调查存在重大差异(p p 结论:发现的常见 AEs 信号与药物标签中记录的一致。然而,诸如肿瘤溶解综合征、皮肤变色和色素失调等未在标签中列出的 AEs 值得特别关注。必须密切监测并及时处理患者的皮肤和实验室指标异常,以保障用药安全。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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