PMID- 36794497 OWN - NLM STAT- MEDLINE DCOM- 20231102 LR - 20231102 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 22 IP - 7 DP - 2023 Jul-Dec TI - Application of tree-based machine learning classification methods to detect signals of fluoroquinolones using the Korea Adverse Event Reporting System (KAERS) database. PG - 629-636 LID - 10.1080/14740338.2023.2181341 [doi] AB - BACKGROUND: Safety issues for fluoroquinolones have been provided by regulatory agencies. This study was conducted to identify signals of fluoroquinolones reported in the Korea Adverse Event Reporting System (KAERS) using tree-based machine learning (ML) methods. RESEARCH DESIGN AND METHODS: All adverse events (AEs) associated with the target drugs reported in the KAERS from 2013 to 2017 were matched with drug label information. A dataset containing label-positive and -negative AEs was arbitrarily divided into training and test sets. Decision tree, random forest (RF), bagging, and gradient boosting machine (GBM) were fitted on the training set with hyperparameters tuned using five-fold cross-validation and applied to the test set. The ML method with the highest area under the curve (AUC) scores was selected as the final ML model. RESULTS: Bagging was selected as the final ML model for gemifloxacin (AUC score: 1) and levofloxacin (AUC: 0.9987). RF was selected in ciprofloxacin, moxifloxacin, and ofloxacin (AUC scores: 0.9859, 0.9974, and 0.9999 respectively). We found that the final ML methods detected additional signals that were not detected using the disproportionality analysis (DPA) methods. CONCLUSIONS: The bagging-or-RF-based ML methods performed better than DPA and detected novel AE signals previously unidentified using the DPA methods. FAU - Jang, Min-Gyo AU - Jang MG AD - College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, Republic of Korea. FAU - Cha, SangHun AU - Cha S AD - Department of Statistics, College of Natural Sciences, Kyungpook National University, Daegu, Republic of Korea. FAU - Kim, Seunghwak AU - Kim S AD - Department of Statistics, College of Natural Sciences, Kyungpook National University, Daegu, Republic of Korea. FAU - Lee, Sojung AU - Lee S AD - Department of Statistics, College of Natural Sciences, Kyungpook National University, Daegu, Republic of Korea. FAU - Lee, Kyeong Eun AU - Lee KE AD - Department of Statistics, College of Natural Sciences, Kyungpook National University, Daegu, Republic of Korea. FAU - Shin, Kwang-Hee AU - Shin KH AUID- ORCID: 0000-0002-0915-2700 AD - College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, Republic of Korea. LA - eng PT - Journal Article DEP - 20230223 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Fluoroquinolones) RN - 6GNT3Y5LMF (Levofloxacin) RN - 5E8K9I0O4U (Ciprofloxacin) SB - IM MH - Humans MH - *Fluoroquinolones/adverse effects MH - *Levofloxacin MH - Ciprofloxacin MH - Machine Learning MH - Republic of Korea OTO - NOTNLM OT - Disproportionality analysis OT - fluoroquinolones OT - signal detection OT - spontaneous reporting system OT - tree-based machine learning EDAT- 2023/02/17 06:00 MHDA- 2023/02/17 06:01 CRDT- 2023/02/16 04:04 PHST- 2023/02/17 06:01 [medline] PHST- 2023/02/17 06:00 [pubmed] PHST- 2023/02/16 04:04 [entrez] AID - 10.1080/14740338.2023.2181341 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2023 Jul-Dec;22(7):629-636. doi: 10.1080/14740338.2023.2181341. Epub 2023 Feb 23.