definiens: means any untoward medical occurrence i n a patient orclinical trial subject who has been administered a PR Produc t, where the untoward medicaloccurrence is temporally associated with the use of the PR Pr oduct, whether or not consideredrelated to the PR Product . An Adverse Event can therefore be a ny unfavourable and unintended sign(including an abnormal laboratory finding ) symptom or dise ase ( new or exacerbated ) temporallyassociated with the use of a PR Product . For a marketed PR Prod uct, this can also include failure toNSDl93926.2produce expected benefits ( i.e. lack of efficacy ), and adve rse events associated with circumstances ofabuse or misuse . In addition to the foregoing, in the context of clinical trials, an Adverse Event willalso mean events associated with or possibly attributable t o the clinical trial protocol design orclinical trial procedures