Serious Event
Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.
Serious Event path is as follows:
Study -> Results Section -> Adverse Events Module -> Serious Event
Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats