Adverse Effects in Clinical Trials with Repeated Measures

Abstract

This chapter assesses adverse-effect-analyses in more longitudinal studies adjusted for time effects rather than those with single endpoint measurements. Mixed linear models are particularly suitable for the purpose, because within-subject differences receive fewer degrees of freedom, than they do with traditional general linear models. The mixed effect model in our example was able to demonstrate a significant adverse effect of the independent type, while the classical repeated measures analysis was unable to do so. In the data example the adverse effect was, thus, significantly more present in one group than it was in the other.