Analysis of Longitudinal-Ordered Categorical Data for Muscle Spasm Adverse Event of Vismodegib: Comparison Between Different Pharmacometric Models.

ABSTRACT: Longitudinal-ordered categorical data, common in clinical trials, can be effectively analyzed with nonlinear mixed effect models. In this article, we systematically evaluated the performance of three different models in longitudinal muscle spasm adverse event (AE) data obtained from a clinical trial for vismodegib: a proportional odds (PO) model, a discrete-time Markov model, and a continuous-time Markov model. All models developed based on weekly spaced data can reasonably capture the proportion of AE grade over time; however, the PO model overpredicted the transition frequency between grades and the cumulative probability of AEs. The influence of data frequency (daily, weekly, or unevenly spaced) was also investigated. The PO model performance reduced with increased data frequency, and t

SUBMITTER: Lu T 

PROVIDER: S-EPMC7020275 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature