ABSTRACT

Many clinical trials use outcome variables that are binary in nature, that is, there are two possible outcomes for each subject. Without loss of generality, these two outcomes are called “success” and “failure.” Other terms used are “with an event” and “without the event.” Usually there are qualitative differences between these two outcomes, in that one outcome is always preferred over the other. Specically excluded from this class of outcome variables are outcomes of a time-to-event endpoint where we are interested in the length of time until an event (as well as the occurrence of the event are of interest), or outcomes where we are interested in the magnitude in gradations between success and failure.