Adverse On-Therapy Experiences

Abstract

When the status of health is examined minutely by periodic biochemical measurements, meticulously detailed investigations of the eye, heart, or kidney, and leisurely inquiry about symptoms, variations from the baseline or normal ranges are encountered 5 to 15% of the time. Should an intercurrent viral infection arise, extreme muscular exertion occur, or severe anxiety develop, biochemical and symptomatic abnormalities will concomitantly increase. Mild symptoms of anorexia, irritability, fatigue, altered sleep, and constipation are similarly variable and commonplace. The problem arising in any study is to ascertain which symptoms or laboratory variations may be caused by the agent under study and, therefore, may be classified as adverse drug reactions (ADRs), and which changes are from other causes. These symptoms or variations are commonly referred to as adverse on-therapy experiences (AOTEs). This chapter suggests an approach for managing adverse experiences in cases where the protocol does not provide guidelines for withdrawal of medication or evaluation of the events.