Also known as side effects, adverse events are the secondary, usually negative, effects caused by medicine. They are recorded as the percentage of patients who experience the adverse event. For example, if 10 people out of 100 in a clinical trial take a medicine and develop a headache, then 10% of the study participants experienced this adverse event. A well-tolerated medicine is associated with low rates of adverse events. Close Window
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 adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or no related to the medicinal (investigational) product. (TGA)*or medical intervention involving novel drug, surgical or other therapeutic or preventive procedure or diagnostic device or service including so-called 'natural' therapies and other forms of complementary medicines. See also: Adverse Drug Reaction, Unexpected Adverse Drug Reaction and Serious Adverse Event Therapeutic Goods Administration TGA Guidance on Good Clinical Practice (CPMP/ICH/135/95) International Conference on Harmonization (ICH) Definitions for Adverse Drug Reaction, Unexpected Adverse Drug Reaction and Serious Adverse Event