Premarketing adverse drug experiences: data management procedures. Unexpected death occurring early in clinical trials.

Reporting of adverse events occurring during clinical trials of investigational drugs is a complex and controversial issue. Even the interpretation of the term, "adverse event," cannot be agreed upon by researchers. The ultimate adverse event, death, presents even a greater challenge. This paper presents an actual case of death during a clinical trial to illustrate a methodological approach to deal with such an event.