Clinical trials can result in several complications related to the medical conditions of the participants involved in a clinical trial. During a clinical trial, these kinds of situations or events might happen. It is important to have a proper segmentation of events so that a quick and effective management plan can be implemented immediately. There are different reporting processes that need to be followed in different events. Two most common events in a clinical trial are Adverse Events (SE) and Serious Adverse Events (SAE).
Adverse Event (AE):
Serious Adverse Event (SAE):
A Serious Adverse Event (SAE) is actually a special case of an adverse event where adverse outcomes are severe. 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.