严重不良事件
指受试者接受试验用药品后出现死亡、危及生命、永久或者严重的残疾或者功能丧失、受试者需要住院治疗或者延长住院时间，以及先天性异常或者出生缺陷等不良医学事件。
------药物临床试验质量管理规范-2020
1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
Any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,- requires inpatient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity,
or
- is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
------ICH GCP E6(R)2-2016
Medical and scientific judgement should be exercised in deciding whetherexpedited reporting is appropriate in other situations, such as important medicalevents that may not be immediately life-threatening or result in death orhospitalisation but may jeopardise the patient or may require intervention toprevent one of the other outcomes listed in the definition above. These shouldalso usually be considered serious.Examples of such events are intensive treatment in an emergency room or athome for allergic bronchospasm; blood dyscrasias or convulsions that do notresult in hospitalisation; or development of drug dependency or drug abuse.
------ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting-1994
重度不良事件
The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache).
------ ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting-1994
重要不良事件
12.3.1.3 Other Significant Adverse Events
Marked haematological and other laboratory abnormalities (other than those meeting the definition of serious) and any events that led to an intervention, including withdrawal of test drug/investigational product treatment, dose reduction, or significant additional concomitant therapy, other than those reported as serious adverse events, should be listed in section 14.3.2.
------ICH E3: Structure and Content of Clinical Study Reports-1995
指的是除严重不良事件外，发生的任何导致采用针对性医疗措施（如停药、降低剂量和对症治疗）的不良事件和血液学或其他实验室检查明显异常。
------药物临床试验数据管理与统计分析的计划和报告指导原则-2016
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