Detecting early safety signals of infliximab using machine learning algorithms in the Korea adverse event reporting system.

ABSTRACT: There has been a growing attention on using machine learning (ML) in pharmacovigilance. This study aimed to investigate the utility of supervised ML algorithms on timely detection of safety signals in the Korea Adverse Event Reporting System (KAERS), using infliximab as a case drug, between 2009 and 2018. Input data set for ML training was constructed based on the drug label information and spontaneous reports in the KAERS. Gold standard dataset containing known AEs was randomly divided into the training and test sets. Two supervised ML algorithms (gradient boosting machine [GBM], random forest [RF]) were fitted with hyperparameters tuned on the training set by using a fivefold validation. Then, we stratified the KAERS data by calendar year to create 10 cumulative yearly datasets, in which

SUBMITTER: Lee JE 

PROVIDER: S-EPMC9436954 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature