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AMIA Annu Symp Proc. 2018 Apr 16;2017:1793-1801. eCollection 2017.

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

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University of Michigan, Ann Arbor, MI, USA.
Division of Applied Regulatory Science, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA.


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.


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