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Cytopenias as Adverse Drug Reactions: A 10-Year Analysis of Reporting Structure, Rate, and Trend.


ABSTRACT: Background/Objectives: Underreporting is very common in drug-induced cytopenias (DICs) due to the late onset of symptoms and the need for laboratory confirmation and monitoring. This research aimed to analyze spontaneously reported adverse drug reaction (ADR) cases of leucopenia, anemia, thrombocytopenia, and total cytopenia, including their reporting structure, rate, and trend, globally (World) and in Serbia. Methods: Based on real-world data from VigiBase, analyses of the DIC reporting structure, rate, and trend over 10 years (2014-2023) were performed. The reporting rate was calculated and expressed as the number of reports per 1,000,000 inhabitants per year (ADR/million/year). Statistics included descriptions, a chi-square test, joinpoint analysis, and measures of variabi

SUBMITTER: Stevic I 

PROVIDER: S-EPMC12845036 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature