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Generating Adverse Event Narratives Using JMP Clinical

The analysis of adverse events (AEs) is an important component for understanding the safety profile of any new therapy under investigation. An AE is any unfavorable experience that occurs during the course of a clinical trial regardless of relationship to study drug.

Of particular importance, serious adverse events (SAEs) are AEs that result in death, are life threatening, require inpatient hospitalization or prolongation of hospitalization, require medical or surgical intervention, result in disability or permanent damage, or are congenital anomalies or birth defects.

When a clinical trial subject has an SAE or other significant adverse event, such as those leading to the discontinuation of the clinical trial, a narrative is written for the clinical study report. This paper introduces the AE Narrative analytical process available in JMP Clinical, which streamlines the time-consuming task of creating patient narratives.

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