Suspected Unexpected Serious Adverse Reactions (SUSAR)

A SUSAR is defined as an untoward and unintended response to a study drug, which is not listed is the applicable product information, and meets one of the following serious criteria: results in death, is life-threatening, requires hospitalisation or prolongation of an existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect