MDDC: An R and Python Package for Adverse Event Identification in Pharmacovigilance Data

Fuente: arXiv
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Autores principales: Liu, Anran, Mukhopadhyay, Raktim, Markatou, Marianthi
Formato: Preprint
Publicado: 2024
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author Liu, Anran
Mukhopadhyay, Raktim
Markatou, Marianthi
author_facet Liu, Anran
Mukhopadhyay, Raktim
Markatou, Marianthi
contents The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products. Various SRS are employed globally, such as the Food and Drug Administration Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase. In the pharmacovigilance literature, numerous methods have been proposed to assess product - adverse event pairs for potential signals. In this paper, we introduce an R and Python package that implements a novel pattern discovery method for postmarketing adverse event identification, named Modified Detecting Deviating Cells (MDDC). The package also includes a data generation function that considers adverse events as groups, as well as additional utility functions. We illustrate the usage of the package through the analysis of real datasets derived from the FAERS database.
format Preprint
id arxiv_https___arxiv_org_abs_2410_01168
institution arXiv
publishDate 2024
record_format arxiv
spellingShingle MDDC: An R and Python Package for Adverse Event Identification in Pharmacovigilance Data
Liu, Anran
Mukhopadhyay, Raktim
Markatou, Marianthi
Computation
Methodology
The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products. Various SRS are employed globally, such as the Food and Drug Administration Adverse Event Reporting System (FAERS), EudraVigilance, and VigiBase. In the pharmacovigilance literature, numerous methods have been proposed to assess product - adverse event pairs for potential signals. In this paper, we introduce an R and Python package that implements a novel pattern discovery method for postmarketing adverse event identification, named Modified Detecting Deviating Cells (MDDC). The package also includes a data generation function that considers adverse events as groups, as well as additional utility functions. We illustrate the usage of the package through the analysis of real datasets derived from the FAERS database.
title MDDC: An R and Python Package for Adverse Event Identification in Pharmacovigilance Data
topic Computation
Methodology
url https://arxiv.org/abs/2410.01168