‘Unexpected serious adverse reaction’ means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information. EU Nr. 536/2014 Art. 2 Abs. 2 (34)

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. ICH-GCP E6(R3)