hepatitis that resolved without hepatic failure). Hospitalisat ion Out-patient treatment in an emergency room is not in itself a serious adverse event, although the reasons for it may be (e.g. bronchospasm, laryngeal oedema). Hospital admissions and/or surgical operations planned before or during a study are not considered adverse events if the illness or disease existed before the patient was enrolled in the study, provided that it did not deteriorate in an unexpected way during the study. Important medical event or medical intervention Medical and scientific judgement should be exercised in deciding whether a case is serious in a situation where important medical events may not be immediately life - threatening or result in death, hospitalisation, disability or incapacity, but may jeopardise the patient or may require medical intervention to prevent one or more outcomes listed in the definition of serious. These should usually be considered as serious.