至于significant adverse event，尽管也有“严重”的含义，但它的重点在于导致的干预或影响，而不是事件本身的严重程度。在ICH E2A和E3指南中，significant不良事件指的是除严重不良事件外，那些导致医疗干预，如停药或改变剂量的事件。因此，翻译时务必注意，serious adverse event应译为“严重不良事件”，...
详见ICH E2A的定义
Gansbacher, B., Report of a second serious adverse event in a clinical trial of gene therapy for X-linked severe combined immune deficiency (X-SCID). Position of the European So- ciety of Gene Therapy (ESGT). J. Gene Med. 2003, 5, 261-262....
Ozempic (semaglutide) is a medication commonly prescribed for managing type 2 diabetes. While effective, it can cause a range of side effects. This guide will help you understand the potential side effects of Ozempic, both common and serious, and provide tips for managing them. ...
Serious side effects Other side effects Professional info FAQ Applies to enalapril: oral solution, oral tablet.Important warnings This medicine can cause some serious health issues Oral route (tablet; solution; powder for solution) Discontinue enalapril maleate as soon as possible when pregnancy is ...
Treatment-related adverse events were developed in 6 patients (23.2%) and worsened in 8 patients (30.8%), and no treatment-related serious adverse events were reported. Conclusions Our findings indicate that ruxolitinib has the potential to increase the likelihood of survival as well as reduce the...
Hy’s law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15(4):241-243. doi:10.1002/pds.1211 PubMedGoogle ScholarCrossref 15. Andrade RJ, Lucena MI, Fernández MC, et al; Spanish Group for the Study of Drug-Induced Liver Disease. Drug-induced ...
Serious Adverse Events. Data for adverse events for treated vs control patients, respectively, are as follows. Gastroduodenal bleeding (data available in 1594 patients) was observed in 65 of 827 (7.9%) vs 56 of 767 (7.3%) (RR, 1.12; 95% CI, 0.81-1.53; P = .50), with no ...
Seven participants had a severe treatment emergent adverse event (TEAE) (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 2 (3.9%)). There were no deaths or serious TEAEs. These data suggest that MDMA-AT reduced PTSD symptoms and functional impairment in a diverse population ...
Serious side effects of Stribild Along with its needed effects, cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention....