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
摘要: Correspondence from The New England Journal of Medicine — A Serious Adverse Event after Successful Gene Therapy for X-Linked Severe Combined Immunodeficiency关键词: Genetics and Reproduction DOI: 10.1056/NEJM200301163480314 被引量: 3534
Understanding the right way to administer drugs is important to reduce any serious adverse drug event. In this analysis we aimed to systematically show the risk of adverse drug events which were observed with 150 mg versus (vs) 300 mg secukinumab for the treatment of moderate to severe ...
Rates of severe ALI could be measured in large cohorts, allowing investigation of hepatotoxicity safety signals from post-marketing adverse event reports. Yet, real-world evidence on rates of severe ALI following initiation of suspected hepatotoxic medications remains unknown. This study evaluated rates ...
General adverse events The most commonly reported side effects included gastrointestinal complaints, abdominal pain, and headaches.[Ref] Gastrointestinal Very common (10% or more): Gastrointestinal complaints (up to 55%), abdominal pain (up to 18%), vomiting (up to 12%) Common (1% to 10%):...
Tenofovir DF: Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash) Common (1% to 10%): Sweating Uncommon (0.1% to 1%): Lipodystrophy Rare (less than 0.1%): Angioedema[Ref]Skin...
Severe hypersensitivity reactions (HSRs) such as anaphylaxis are of great clinical concern because of their life-threatening potential. The adverse events
Serious adverse events were observed in 36 of 225 patients (16%) treated with canakinumab vs 46 of 223 (20.6%) who received placebo. Conclusions and Relevance Among patients hospitalized with severe COVID-19, treatment with canakinumab, compared with placebo, did not significantly increase the ...
Disease related event ECMO: Extra corporal membrane oxygenation eGFR: Estimated glomerular filtration rate EMA: European Medicines Agencies NIV: Non-invasive ventilation PCR: Polymerase chain reaction PROM: Patient related outcomes measures SAE: Serious adverse event ...