Suspected unexpected serious adverse reaction (SUSAR):

: an adverse reaction that meets three criteria: suspected, unexpected and serious.

• •         Suspected: There is a reasonable possibility that the drug caused the adverse drug reaction.

• •         Unexpected: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure or alternative documents according to applicable regulatory requirements; see RSI).

Serious: See above for SAE