In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices. The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter...
FDA Launches Huge Online Database of Adverse EventsJames A. O'Neal
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 ...
The FDA Adverse Event Reporting System is a publicly available database containing information on adverse events and medication error reports submitted to FDA.
The cardiovascular safety of antiobesity drugs—analysis of signals in the FDA Adverse Event Report System DatabaseOver the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity. This study aimed to evaluate ...
1999年创刊 主管: 中国科学技术协会 主办: 中华医学会 基于美国FDA不良事件报告系统数据库的依瑞奈尤单抗风险信号挖掘 孙文芳, 夏彬彬, 成华 Signal mining of adverse events related to erenumab based on 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 A, Malin J, Weiss Smith S: Novel adverse events of bevacizumab in the US FDA adverse event reporting system database: a disproportionality analysis. Drug... Shamloo,K B.,...
Regardless of whether the clinical database is in a format supported by the Catalog, an aCRF should be submitted preferably at the time a protocol is submitted. The aCRF should be provided as a PDF with the file name ‘acrf.pdf.’带注释的病例报告表(aCRF)是一个PDF文档,用于将用于捕获受...
Futela, P., Kowlgi, G.N., DeSimone, C.V. et al. Early insights on adverse events associated with PulseSelect™ and FARAPULSE™: analysis of the MAUDE database. J Interv Card Electrophysiol (2024). https://doi.org/10.1007/s10840-024-01935-3...
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 compare FAERS and JADER, we calculated the signals of adverse events by new quinolones (NQs). Methods: We ...