definiens: ) ill defined as : a ) Iny expenence wllkll is adverse, illCludlllJ wllat are commonly described as adverse or undairable experienca, adverse events, advel'$e ructioll$, side effeclS, or dealh due to any cause anoci.1led WIlli, or ob$erved in conjunction with the use of a drul, biologiCI.I producl, or device in lIurnans, whelher or IlOl considered relaled to the use of Ihal product : • oecurrina in the COUTS < ' of the use of • dru8, biololieal product or device, • LUOCLl.led wllh, or observed in oonJunaloo With product overdO$e, whether iIoCCidenial OT inlenlional, • associaled with, or observed in oonJUlICIion wllh product abuse, and/or • associated with, or observed in conjunction wilh product withdrawal b ) Any silTlificant failure of expected pharmacoloaical or binloaic therapeutIC aClloo ( willi lhe exception of in clinicaltri.lls )