VigiBase

The core statistical engine for mining VigiBase. This methodology identifies drug-event combinations reported more frequently than expected against a background reference set.

• PRR & ROR: Frequentist measures for early flagging.
• EBGM: Bayesian shrinkage metric used by the Uppsala Monitoring Centre to adjust for data sparsity in small report counts.
• IC (Information Component): The specific disproportionality score calculated by the UMC's vigiRank algorithm to prioritize signals.

The Medical Dictionary for Regulatory Activities is the standardized international terminology used to code adverse event reports in VigiBase. It provides a hierarchical structure for consistent indexing.

• LLTs (Lowest Level Terms): The most granular verbatim descriptions.
• PTs (Preferred Terms): The standardized medical concepts used for statistical analysis.
• SMQs (Standardised MedDRA Queries): Pre-defined groupings of terms to retrieve cases related to specific syndromes, such as anaphylactic reaction or acute pancreatitis.

The ICH electronic standard for the structured exchange of Individual Case Safety Reports (ICSRs) . This XML-based messaging format enables automated data submission to VigiBase from national pharmacovigilance centers and pharmaceutical companies.

• Defines the exact data elements for patient characteristics, suspect drugs, and reaction descriptions.
• Ensures semantic interoperability between disparate safety systems globally.
• Replaces older E2B (R2) formats with enhanced fields for medical history and laboratory data.

The rigorous process following a statistical alert in VigiBase. It confirms whether a new causal association or a new aspect of a known association truly exists.

• Causality Assessment: Evaluating the likelihood of a drug-event link using factors like temporal relationship and dechallenge/rechallenge.
• Confounding by Indication: A critical bias where the treated disease, not the drug, causes the event.
• Involves clinical review of aggregated case narratives, literature evidence, and non-clinical data before escalation.

Major regional safety databases that feed into and complement VigiBase's global dataset.

• FAERS (FDA Adverse Event Reporting System): The U.S. database containing millions of spontaneous reports from healthcare professionals, consumers, and manufacturers.
• EudraVigilance: The centralized European Economic Area database managed by the EMA.
• VigiBase aggregates data from these and other national systems, providing the largest pooled dataset for detecting rare, global safety signals.

A statistical technique critical to VigiBase analytics that prevents false-positive signals from drug-event combinations with very low report counts.

• Shrinks observed disproportionality scores toward a null value based on the precision of the estimate.
• The Empirical Bayes Geometric Mean (EBGM) is the posterior mean of the relative reporting ratio after applying shrinkage.
• Ensures that a single report of a rare event does not trigger a spurious alert, stabilizing the signal detection process.