What is the difference between ae and sae

Adverse Event AE :. It includes following events:. A clinical trial always carries the risk of undesired outcomes that can even be life-threatening in some cases. Thus, the awareness about the classification of events into Adverse Events and Serious Adverse Events can be extremely helpful in minimizing damage and saving lives of the participants.

Your email address will not be published. Published by Doctor Erick at October 27, Adverse Event AE : Adverse Events refers to any situation where the candidates participating in a clinical trial shows some adverse medical symptoms.

Severe AE is one class of AEs with severity old term intensity classified as 'severe'. On the other hand, Severity of an AE is a point on an arbitrary scale of intensity of the adverse event in question. The terms "severe" and "serious" when applied to adverse events are technically very different. They are easily confused but can not be used interchangeably, require care in usage. A headache is severe, if it causes intense pain. Every symptom, every disease and every adverse event including a runny nose during the cold season and abnormal laboratory values that a patient experiences after administration of a study drug is classified as an adverse event AE.

In this context, it makes no difference whether a causal relationship with the treatment is suspected or whether the event is completely unrelated to the study drug. The investigator study doctor assesses the severity of an adverse event. Non-serious AEs are recorded in the source data patient file and in the CRF case report form for clinical trials by the investigator within the deadlines stipulated in the protocol.

Serious adverse events, on the other hand, are subject to special reporting obligations and deadlines. A serious adverse event SAE is any untoward occurrence that at any dose is fatal or life-threatening, requires inpatient treatment or a prolongation thereof, leads to persistent or significant disability or incapacity, or results in a congenital anomaly or a birth defect.

Examples of an SAE include, for example, a heart attack or prolonged hospitalisation due to elevated liver values.