definiens: means the minimum criteria for an Adverse Drug Event report and must include the following : ( a ) name.ofthedmg ; ( b ) a description of the adverse dmg event ; ( c ) patient identifiers ( anyone or more of name, initials or clinical investigation number, age, sex or weight ) ; and ( d ) an identifiable source of the report ;, is any Adverse Drug Event other than a Serious Adverse'Drug Event ; is any Adverse Drug Event that satisfies one or more of the following criteria : ( a ) fatal ; or ( b ) life - threatening ; or ( c ) causing disahility or incapacity ; or ( d ) causing or prolonging hospitalization ; or ( e ) congenital anomaly or cancer ; or ( f ) requiring medical intervention to prevent permanent impainnent or damage ; are repOIts from any non - c1inicaltrial source, including regulatory agencies, consumers and literature ;