不良事件报告系统
食品药品监督管理局
不利影响
医学
事件(粒子物理)
药品
事件研究
内科学
药理学
古生物学
背景(考古学)
生物
物理
量子力学
作者
Callie Berkowitz,Samuel Wilson,Nigel S. Key,Patrick Ellsworth
标识
DOI:10.1016/j.jtha.2024.04.027
摘要
We read with interest the recently published report "Comparison of thrombotic adverse events in patients treated with factor VIII products and emicizumab using the 2018-2022 US Food and Drug Administration Adverse Event Reporting System data" by Cho et al. [1]. However, we have significant concerns about the authors' methodologic approach using pharmacovigilance data, specifically the failure to critically analyze and account for reporting biases.
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