Before revision: An adverse event does not necessarily have a causal relationship with the treatment, it can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.ICH GCP AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee.
After revision: AllAn adverse event does not necessarily have a causal relationship with the treatment, it can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.ICH GCP AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee.