PMID- 29854250 OWN - NLM STAT- MEDLINE DCOM- 20190226 LR - 20190226 IS - 1942-597X (Electronic) IS - 1559-4076 (Linking) VI - 2017 DP - 2017 TI - Towards precision informatics of pharmacovigilance: OAE-CTCAE mapping and OAE-based representation and analysis of adverse events in patients treated with cancer drugs. PG - 1793-1801 AB - 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. FAU - Wong, Mei U AU - Wong MU AD - University of Michigan, Ann Arbor, MI, USA. FAU - Racz, Rebecca AU - Racz R AD - University of Michigan, Ann Arbor, MI, USA. AD - Division of Applied Regulatory Science, Office of Clinical Pharmacology, Food and Drug Administration, Silver Spring, MD, USA. FAU - Ong, Edison AU - Ong E AD - University of Michigan, Ann Arbor, MI, USA. FAU - He, Yongqun AU - He Y AD - University of Michigan, Ann Arbor, MI, USA. LA - eng PT - Journal Article DEP - 20180416 PL - United States TA - AMIA Annu Symp Proc JT - AMIA ... Annual Symposium proceedings. AMIA Symposium JID - 101209213 RN - 0 (Antineoplastic Agents) SB - IM MH - Antineoplastic Agents/*adverse effects/therapeutic use MH - *Biological Ontologies MH - Drug-Related Side Effects and Adverse Reactions/*classification MH - Humans MH - Medical Informatics MH - Neoplasms/*drug therapy MH - *Pharmacovigilance MH - Semantics MH - Severity of Illness Index PMC - PMC5977606 EDAT- 2018/06/02 06:00 MHDA- 2019/02/27 06:00 PMCR- 2018/04/16 CRDT- 2018/06/02 06:00 PHST- 2018/06/02 06:00 [entrez] PHST- 2018/06/02 06:00 [pubmed] PHST- 2019/02/27 06:00 [medline] PHST- 2018/04/16 00:00 [pmc-release] AID - 2731377 [pii] PST - epublish SO - AMIA Annu Symp Proc. 2018 Apr 16;2017:1793-1801. eCollection 2017.