Adverse Event Definition Sample Clauses

Adverse Event Definition. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. This includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug.

Adverse Event Definition. An Adverse Event (“AE”) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. This includes the following: a) an adverse event occurring in the course of the use of a product in professional practice; b) an adverse event occurring from abuse/misuse of the product; c) an adverse event occurring from the withdrawal of the product; d) any significant failure of expected pharmacological action; e) any accidental exposure (with or without an AE); f) any medication error, with or without an AE (i.e., administration of expired product); g) any overdose with the use of the product; h) any pregnancy with the use of the product; i) any exposure during breastfeeding; j) any suspected transmission of infectious agents; k) an unexpected therapeutic or clinical benefit from use of the product.