ICH E6(R3) – 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., the RSI, see glossary term contained within the Investigator’s Brochure or alternative documents according to applicable 2065 regulatory requirements. Refer to ICH E2F Development Safety Update Report for more information about RSI.