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A serious adverse event (SAE) in human drug trials are defined as any untoward medical occurrence that at any dose #results in death, #is life-threatening #requires inpatient hospitalization or causes prolongation of existing hospitalization #results in persistent or significant disability/incapacity, #is a congenital anomaly/birth defect, or #requires intervention to prevent permanent impairment or damage.〔http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm〕 The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”〔 ==Research== Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that these events are often inadequately reported in publicly available reports. Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit. To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Serious adverse event」の詳細全文を読む スポンサード リンク
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