Reply: [Post-marketing safety concerns with Lecanemab: a disproportionality analysis using the FDA adverse event reporting system]

回复:[关于Lecanemab上市后安全性问题的分析:基于FDA不良事件报告系统的比例失衡分析]

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Abstract

In this article, we have carefully read the author's comments on our published article regarding the post-marketing safety concerns of lecanemab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Pharmacovigilance studies based on the disproportionality analysis through the case/non-case design are common, and the details of this method deserve attention. We acknowledged the author's perspectives on the term "signal of disproportionate reporting (SDR)", and make some explanations on the SDR results for pancreatic carcinoma and the deduplication methods.

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