The FDA Adverse Event Reporting System is a publicly available database containing information on adverse events and medication error reports submitted to FDA.
其中,FDA不良事件报告系统 (FDA Adverse Event Reporting System, FAERS) 是OSE安全审查人员使用的一种工具。FAERS包含数百万份个案安全报告 (individual case safety reports, ICSR),包括来自制药公司等机构的强制性安全报告和来自病人和保健专业人员的自愿性MedWatch报告。 然而,FAERS收集的数据量是巨大的。近年来,FAER...
美国 FDA 不良事件报告系统(FDA Adverse Event Reporting System,FAERS)是较为成熟的药物 警戒数据库,接收来自全球多个国家的不良反应/ AE 报告.美国 FDA 已将分析 FAERS 数据库得到 的药物安全信息用于发布药物安全通讯,药物警报 和声明,用药指南,以及修订药品说明书等[11].数 据挖掘是指从大量的数据中通过一些...
美国 FDA 不良事件报告系统(FDA Adverse Event Reporting System,FAERS)是药品上市后安全 性评价的信息来源之一,可在一定程度上反映真实 世界药物不良事件(adverse event,AE)的发生情况,常用于药物警戒信号挖掘[6-7].为此,本研究提 取 FAERS 数据库相关数据挖掘卡泊芬净,米卡芬 净和阿尼芬净的 AE 风险信号,为...
Method: We utilized OpenVigil 2.1 to query the FDA Adverse Event Reporting System database and retrieved reports by the generic name "ticagrelor" published between 1 October 2010 and 31 March 2023. Adverse drug events (ADEs) were classified and described according to the pr...
关键词: 乌帕替尼, FAERS, 不良反应事件, 数据挖掘, 黑框警告, 药物警戒 Abstract: Objective: To promote safe upadacitinib prescribing by mining and evaluating the upadacitinib adverse reaction events(ADE) signals from the FDA Adverse Event Reporting System (FAERS). Methods: In the FAERS, “up...
Pharmacovigilance analysis of orlistat adverse events based on the FDA adverse event reporting system (FAERS) database Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, we analyzed the signals of potential adverse events (AEs) o... J Zhu,M Hu,Y...
8FDA Adverse Event ReportingSystem (FAERS) La test Quarterly Da ta Files-https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEff ects/ucm082 193.htm. FDA不良事件报告系统(FAERS)最新季度数据文件...
FDA Adverse Event Reporting System (FAERS) Quarterly Data Files FDA不良事件报告系统(FAERS)季度数据文件Downloadable data files. 可下载的数据文件 FDA Adverse Event Reporting System (FAERS) Public Dashboard FDA不良事件报告系统(FAERS)公告板 Inactive Ingredient Search for Approv...
由于上市时间短,国内医务人员对地舒单抗的安全性数据如不良反应/不良事件(adverse events,AE)发生情况可能了解较少。美国FDA不良事件报告系统(FDA Adverse Event Reporting System,FAERS)是一个公共的、自愿的、自发的报告系统,包含了美国和其他地区的卫生专业人员、消费者和药品生产企业提交的药物AE和用药错误报告信息,...