From: Pharmacovigilance of antimalarial treatment in Africa: is it possible?
ADVERSE EVENT |
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Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (ICH guidelines). |
ADVERSE DRUG REACTION |
Any noxious and unintended responses to a medicinal product related to any dose. The phrase "responses to a medicinal product" implies that a causal relationship between a medicinal product and an adverse event (AE) is at least a reasonable possibility (i.e. the relationship can not be ruled out). |
UNEXPECTED ADVERSE DRUG REACTION |
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigators brochure for an unapproved product or package insert/summary of product characteristics for an approved product (ICH guidelines). |
SERIOUS ADVERSE EVENT |
Any untoward medical occurrence that at any dose: results in death; is life-threatening; requires hospitalization (other than for drug administration) or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect and also other important medical events that jeopardise the subject or require intervention to prevent one of the other outcomes listed in the definition above). |