Seriousness of adverse events: medical judgment is important

Editor—In his letter asking for definition of “serious” and “severe” adverse reactions Frankenfeld does not take into account what the Council for International Organisations of Medical Sciences specifies.¹,²

Important medical events that may not be immediately life threatening or result in death or hospitalisation but may jeopardise the patient or require intervention to prevent one of the other outcomes listed in the definition of seriousness (death, life threatening, hospitalisation or extended existing hospitalisation, severe disability or incapacity, congenital anomaly or birth defect) should also be considered as serious. Seriousness criteria therefore do not need redefinition, but good medical judgment should be exercised when deciding if an adverse event or reaction is or is not serious.