 Endpoint-specific rare-event sample size

A sample size calculation for a binary endpoint requires its own baseline probability, not merely the rate of a related outcome. A fatal-event probability equals the probability of the underlying event times its conditional fatality probability; knowing only that product does not identify the incidence of all events. Thus a mortality rate can size a mortality trial but cannot determine the size for all fatal and nonfatal events without further assumptions. The significance level, allocation, target statistical power and effect definition must also be specified.