ArticleCPT: pharmacometrics & systems pharmacology2020
Analysis of Longitudinal-Ordered Categorical Data for Muscle Spasm Adverse Event of Vismodegib: Comparison Between Different Pharmacometric Models.
Article in CPT: pharmacometrics & systems pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
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- Role of MZB1 in disease pathogenesis: current insights and future directions.Clinical and experimental medicine · 2026Review
- Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- A Novel Two-Part Mixture Model for the Incidence and Time Course of Cytokine Release Syndrome After Elranatamab Dosing in Multiple Myeloma Patients.Clinical pharmacology and therapeutics · 2025Article
- A tutorial on pharmacometric Markov models.CPT: pharmacometrics & systems pharmacology · 2025Article
- Exposure-response modeling for nausea incidence for cotadutide using a Markov modeling approach.CPT: pharmacometrics & systems pharmacology · 2024Article
- Longitudinal efficacy and safety modeling and simulation framework to aid dose selection of belantamab mafodotin for patients with multiple myeloma.CPT: pharmacometrics & systems pharmacology · 2023Article
- A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Evaluation of patient-reported severity of hand-foot syndrome under capecitabine using a Markov modeling approach.Cancer chemotherapy and pharmacology · 2020Observational
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Authors and funding
4 authors.
Funding
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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 the discrete-time Markov model failed to describe unevenly spaced data, but the continuous-time Markov model performed consistently well. Clinical trial simulations were conducted to illustrate the muscle spasm resolution time profile during the 8-week dose interruption period after 12 weeks of continuous treatment.
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