Modeling Exposure-Driven Adverse Event Time Courses in Oncology Exemplified by Afatinib.
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ABSTRACT:
SUBMITTER: Niebecker R
PROVIDER: S-EPMC6482278 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
Publications
Modeling Exposure-Driven Adverse Event Time Courses in Oncology Exemplified by Afatinib.
Niebecker Ronald R Maas Hugo H Staab Alexander A Freiwald Matthias M Karlsson Mats O MO
CPT: pharmacometrics & systems pharmacology 20190227 4
Models were developed to characterize the relationship between afatinib exposure and diarrhea and rash/acne adverse event (AE) trajectories, and their predictive ability was assessed. Based on pooled data from seven phase II/III clinical studies including 998 patients, mixed-effects models for ordered categorical data were applied to describe daily AE severity. Clinical trial simulation aided by trial execution models was used for internal and external model evaluation. The final exposure-safety ...[more]
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