VigiBase Disproportionality Analysis

Comparisons

Evidence quality

Where it comes from

Highlighted claims

• The study used VigiBase, the WHO global database of individual case safety reports. — Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review
• The primary analysis population included more than 6.1 million reports involving at least one of the 141 immunomodulators. — Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review
• The analysis was observational, retrospective, descriptive, and pharmacovigilance-based. — Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review
• Cases were reports containing the MedDRA preferred term for atrial fibrillation, while non-cases were all reports without atrial fibrillation. — Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review
• The study applied Bonferroni correction because 141 drugs were tested simultaneously. — Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review