Towards precision informatics of pharmacovigilance: OAE-CTCAE mapping and OAE-based representation and analysis of adverse events in patients treated with cancer drugs.

Journal: AMIA ... Annual Symposium proceedings. AMIA Symposium
Published Date:

Abstract

A critical issue in the usage of cancer drugs is its association with various adverse events (AEs) in some, but not all, patients. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) is a controlled terminology for AE classification and analysis in cancer clinical trials. The Ontology of Adverse Events (OAE) is a community-based ontology in the domain of AEs. In this study, OAE was first updated by including AE severity grading and OAE-CTCAE mapping. An OAE subset containing CTCAE-related terms and their associated OAE terms was generated to facilitate term usage. A use case study based on a published cancer drug clinical trial demonstrates that OAE provides better hierarchical representation, includes semantic relations, and supports automated reasoning. Demonstrated with a single patient analysis, the OAE framework supports precision informatics for representing AEs and related genetic and clinical conditions in individual patients treated with cancer drugs.

Authors

  • Mei U Wong
    University of Michigan, Ann Arbor, MI, USA.
  • Rebecca Racz
    University of Michigan Medical School, Ann Arbor, MI 48109 USA.
  • Edison Ong
    University of Michigan Medical School, Ann Arbor, MI 48109, USA.
  • Yongqun He
    University of Michigan Medical School, Ann Arbor, MI 48109 USA ; Unit for Laboratory Animal Medicine, Department of Microbiology and Immunology, Center for Computational Medicine and Bioinformatics, and Comprehensive Cancer Center, University of Michigan Medical School, 1301 MSRB III, 1150 W. Medical Dr., Ann Arbor, MI 48109 USA.