VigiBase Disproportionality Analysis
Cases were reports containing the MedDRA preferred term for atrial fibrillation, while non-cases were all reports without atrial fibrillation. The primary analysis population included more than 6.1 million reports involving at least one of…
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Cases were reports containing the MedDRA preferred term for atrial fibrillation, while non-cases were all reports without atrial fibrillation. The primary analysis population included more than 6.1 million reports involving at least one of the 141 immunomodulators. The analysis was observational, retrospective, descriptive, and pharmacovigilance-based. The study applied Bonferroni correction because 141 drugs were tested simultaneously. The study used VigiBase, the WHO global database of individual case safety reports.