The aim of this study was to identify adverse drug reactions (ADRs) related to eplerenone using the FDA Adverse Event Reporting System (FAERS) database. By identifying previously unreported AEs, the study could potentially contribute to updating the drug's label. Meth...
What is the FDA Adverse Event Reporting System? The FDA Adverse Event Reporting System (FAERS) is a database that includes reports of adverse events, medication errors, and product quality complaints that lead to adverse events, all of which have been submitted to the FDA. These reports ...
(2)“前哨行动”提高了FDA对已上市医疗产品安全性的事前监测能力,同时也是对现行不良反应报告系统(Adverse Event Reporting System,FAERS)的补充。 5.“前哨行动”的成就 至今为止,该计划的实施已取得多方面的成就包括: (1)建立哨兵运行中心(Sentinel Operations Center); (2)创建了通用数据模型(common data model)...
关键词 注射用紫杉醇(白蛋白结合型);美国 FDA 不良事件报告系统;不良事件;药品不良反应;信号挖掘 ADR Signal Mining of Paclitaxel for Injection (Albumin-bound Type) Based on FDA Adverse Event Database WANG Yuwei1,MENG Long2,LIU Xiao3(1. Radiotherapy Center,Chongqing University Cancer Hospital, ...
498 例严重 AE 中,共挖掘出 5 个风险信号,其 中感染性肺炎,横纹肌溶解为说明书中未记载的不 表 2 美国 FAERS 数据库中按 ROR 值排序的玛巴洛沙韦相关不良事件风险信号 Tab 2 Risk signals of baloxavir marboxil⁃related adverse events in the FAERS database sorted by ROR value 首选术语 热性惊厥 ...
Methods The US FDA Adverse Event Reporting System database was searched, and the adverse event (AE) reports on psy- chiatric disorders from the third quarter of 2012 to the third quarter of 2021, which judged perampanel as the primary suspect drug were collected. The expression of AE was ...
Novel Adverse Events of Bevacizumab in the US FDA Adverse Event Reporting System Database Novel adverse events of bevacizumab in the US FDA adverse event reporting system database: a disproportionality analysis. Drug Saf. 35(6), 507-518 (... Behrooz,K.,Shamloo,... - 《Drug Safety》 被引...
关键词 利伐沙班;美国 FDA 不良事件报告系统;药品不良反应;信号挖掘;比例报告比法;报告比值比法 ADR Signal Mining of Rivaroxaban Based on FDA Adverse Event Reporting Database WU Yuanyuan1,2,3,ZHENG Shufen2,3,ZHONG Shilong1,2,3(1. School of Biology and Biological Engineering, South China ...
Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products) 紫皮书(FDA许可(批准)的生物制品数据库) 2020.3.23 FDA将生物制品从橙皮书中移除,并为其单独成立了紫皮书板块,这一板块作为较新的版块,收录了细胞、血液、基因治疗、疫苗等各类生物制品的...
Objective: Signal detection by analyzing adverse event spontaneous report databases is used to monitor drug safety. One of the major spontaneous report databases is the FDA Adverse Event Reporting System (FAERS). Recently, the Japanese Adverse Drug Event Report database (JADER) was released. To com...