A Serious Adverse Event (SAE) is an adverse event associated with the use of a medical product that is of significant concern due to its severity. SAEs are characterized by one or more of the following criteria: the event results in death, is life-threatening, necessitates in-patient hospitalization or prolongation of an existing hospital stay, leads to persistent or significant disability or incapacity, or involves the occurrence of a congenital anomaly or birth defect. SAEs are closely monitored and reported as they represent critical safety issues requiring immediate attention and assessment within the healthcare and regulatory contexts.
Confounding by Indication
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