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Abstract:
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Assessment of drug safety typically involves estimation of occurrence rate of adverse events. Most often, the crude percentage (subject incidence) is used to estimate adverse event rate. However, in some situations, the exposure adjusted incidence rate (EAIR) and exposure adjusted event rate (EAER) may be more appropriate measures to account for the potential difference in the duration of drug exposure or the follow-up time among individuals, and to capture the multiple occurrences of certain adverse events for a subject. In this paper, we establish the asymptotic properties of the EAIR and EAER under certain assumptions, and propose a general approach for variance estimation of the rates and for calculating the confidence intervals of the rate differences between two groups. The methodology is illustrated by simulation studies and applications in a clinical trail.
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