Assessment of Adverse Event Data in Large-Scale Clinical Trials

Abstract

The what, when, and how to assess adverse event data collected in large-scale clinical trials will be discussed. The categories of adverse events are: serious life-threatening events, major events, and minor events. In the case of life-threatening events, the company should be notified immediately. The major events are those which require the drug to be discontinued because of an adverse event. The minor events are those which do not require stoppage of the drug. Details concerning the statistical evaluation of adverse event data in controlled and uncontrolled studies are described. In summary, the assessment of adverse event data in large-scale clinical trials must be considered when the protocol is being written.