Table 1 Important definitions for PV (ICH guidelines [11])

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).