adverse event

OBJECTIVE: To discuss the concepts and methods of medical device adverse event monitoring and risk man-agernent.

目的: 初步探讨医疗器械不良事件监测和风险管理的概念和方法.

As well, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.

并且，当使用Botox已批准的剂量用于治疗眼皮痉挛或“斗鸡眼”（crossed eyes）时亦未见因毒素作用远端扩散而导致的最终严重不良事件报道。

Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System ( AERS);

季度报告列出某些被评估有潜在安全问题的药物，这是基于对FDA不良反应事件报告系统内信息的审查。

the signal is denoted as possible causal relationship between drug and adverse event, which is unknown or can not be fully confirmed by the previous literature.

所谓的ADR信号指的是药品与不良事件间可能存在因果关系的报告信息，这种关系是未知的或者以前的文献资料不能充分证实的。

Exposure risk, suspected sub-clinical infection rate and adverse event rate were compared between the three groups.

比较各组间暴露危险因素差异、可疑隐性感染率和不良反应出现率。

Only 5 subjects discontinued early due to an adverse event ( 3 in the RLX group and 2 in the placebo group).

仅有5例因不良事件而提前退出研究（RLX组3例，安慰剂组2例）。

seven patients in each group had an adverse event related to their procedure.

各组均有7位病人出现与操作相关的负性事件.

But even ifyou are strong enough to persist the obstacle course of life and work, sometimes you will encounter an adverse event that will completely knock you on your back.

但是即使你足够坚强并能够在生活和工作的障碍重重的道路上挺进，有时候你也会遭遇逆境，它将会在背后给你狠狠一击。

Were there written up-to-date policies and procedures that addressed the work processes related to the adverse event or close call?

与不良事件的发生或即将发生有关的工作流程，其政策和程序是否有更新？

Were the staff involved in the adverse event or close call properly qualified and trained to perform their functions?

牵涉不良事件当时和即将发生的员工，是否有适当的认证及训练以执行其职务？

there was no imri-related adverse event occurred.

无iMRI相关不良事件发生.

Drug discontinuation due to an adverse event was also more frequent in the sirolimus cohort compared to those patients continued on CNI.

在西罗莫司组中因不良事件而导致停药的也多于继续使用CNI治疗的患者。

adverse event rate in two groups were low, and most adverse events were local reaction such as dry pharynx and excessive phlegm.

两组不良反应发生率均低，以咽干、声嘶等局部反应为主。

Objective we analyzed 324 reports on adverse event that doubted to be aroused by medical device to evaluate the usability of those reports, explore the method to monitoring security in the course of using medical device and the pattern to monitoring adverse event aroused by medical device.

目的对324例可疑医疗器械不良事件报告进行分析，评价报告可利用性，探索安全使用医疗器械监测手段及医疗器械不良事件监测模式。

Study of active monitoring model on adverse event of medical device

医疗器械不良事件主动监测模式探讨

No data are available to support a correlation between RGV and adverse event rates.

目前尚无数据说明RGV与不良事件率之间的联系。

Results. Of 25 subjects enrolled, scleral icterus was the most common adverse event ( 3 patients [ 12.5 % ] ).

结果: 在25名受试者中, 巩膜黄染为最常见的副作用 ( 3例, 12.5% ).

In this case, it might spuriously influence the specificity of the association between vaccine and adverse event.

这可能导致疫苗和副反应联系特异性产生假象。

But even if you are strong enough to persist through the obstacle course of life and work, sometimes you will encounter an adverse event that will completely knock you on your back.

但即使你意志坚强，能够挺过生活、工作中的困难，有时你也会遇到逆境，它会在背后给你一击。

The ways of risk identification include adverse event reporting, complaint analysis, patient satisfaction analysis, performance improvement study, review of malpractice, safety investigation, department reporting, oral reporting, third-party accreditation report and review of insurance contract.

医院风险识别的途径包括不良事件报告和分析、不良情绪报告和满意度调查、绩效改进研究、医疗纠纷和事故分析、安全性报告、科室报告、口头报告、第三方认证报告、保险合同回顾等。