Network Analysis for Signal Detection in Spontaneous Adverse Event Reporting Database: Application of Network Weighting Normalization to Characterize Cardiovascular Drug Safety.

ABSTRACT: Signal detection yields confirmed signals in only 2.1%, which imposes a heavy burden on the pharmacovigilance system in the European Union. We aimed to develop a network theoretical metric to increase the confirmed signal ratio of individual case safety report (ICSR) networks. ICSRs of five cardiovascular adverse events were requested from EudraVigilance. We developed Vigilace™, a web-based application to build network representation of ICSRs. Three network-based signal scores, which we termed NEWS (normalized edge weight for signals) scores, were calculated by normalizing the weight of each edge in the report-based weighted network by the weight of the same edge in topological weighted networks. Depending on the third node in topological network edges, we defined full-, adverse event-, an

SUBMITTER: Petervari M 

PROVIDER: S-EPMC9561003 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature