因此，翻译时务必注意，serious adverse event应译为“严重不良事件”，severe adverse event为“重度不良事件”，而significant adverse event则对应“重要不良事件”。翻译中，每一步都要求严谨，通过事实支持，以确保译文的精准无误。这不仅是对专业知识的考验，也是译者专业素养的体现。对于新手翻译者来说...
详见ICH E2A的定义
"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 Society of Gene Therapy (ESGT)." J Gene Med 5: 261-262.Gansbacher, B., Report of a second serious adverse event in a ...
Chest pain, shortness of breath, weakness in one part or side of your body, or slurring of speech. These could be signs of a serious blood clotting event. Upper stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of an esophagus, stomach, or ...
Chest pain, shortness of breath, weakness in one part or side of your body, or slurring of speech. These could be signs of a serious blood clotting event. Upper stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of an esophagus, stomach, or ...
A critical barrier to examining the risks of rare adverse events, such as serious infection, is the lack of sufficiently large sample sizes. In addition, patients with moderate to severe psoriasis may potentially be at higher risk of untoward outcomes, such as serious infection, requiring careful...
Deaths were excluded when documentation suggested a noncardiac cause (eg, motor vehicle crash) or if clinically severe heart disease was present and sudden cardiac death was not unexpected (eg, end-stage congestive heart failure). Stroke was defined as an acute neurologic deficit of sudden onset ...
Only complications severe enough to require re-admission to hospital were included, as these were coded in HES APC. Self-controlled case series We used a self-controlled case series (SCCS) study design (Fig. 1) to estimate the relative risk of serious systemic complications in the first 30 ...
did not report stroke severity, it is known that strokes were severe enough to prompt both a return to the emergency department and to warrant hospital admission (i.e. stroke-related adverse events). Risk of mortality rises nearly 5-fold after an initial miss [70]. Myocardial inf...
There is a clear bias in claims data toward more severe harms, as the likelihood of a claim is linked tightly to injury severity rather than the presence of care process failures (i.e. errors of planning or execution) [40]. Nevertheless, claims might still be representative of diseases ...