adverse reaction (ADR)

Abstract

Reaction which seems to be causally related to intake of a pharmaceutical product and which is “noxious, unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function”; intensity rating scale: mild = awareness of a sign or symptom which is easily tolerated and reversible, mod- adv erate = reversible, but discomfort is enough to cause interference with usual activity, severe = incapacitating with inability to work or undertake usual activity; seriousness: ICH: “a serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose (I) results in death, (ii) is life-threatening (i.e. an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), (iii) requires inpatient hospitalisation or prolongation of existing hospitalisation, (iv) results in persistent or significant disability/incapacity, (v) is a congenital anomaly/ birth defect, or is an other medically important condition” (e.g. increase in the rate of occurrence of an expected sAE, significant hazard such as lack of efficacy, major safety finding from a new animal study);