The Proportional Reporting Ratio (PRR) is the workhorse disproportionality measure in pharmacovigilance. Applied to the FDA Adverse Event Reporting System (FAERS), it typically compares a drug's share of reports for an event against the same share in the *whole database* — an implicit assumption that the non-drug reports are a fair comparator.
Pharmacovigilance teams routinely use disproportionality metrics — Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM) — to prioritize drug-event signals from spontaneous-report systems such as FAERS. Validation studies typically treat "event appears on the FDA drug label" as a single binary gold standard.
**Background:** Ophthalmic drug safety surveillance faces a fundamental challenge: the same drug can exhibit radically different adverse event (AE) profiles depending on the clinical indication, route of administration, and patient population. Traditional pharmacovigilance methods, which aggregate adverse events across all uses of a drug, systematically mask indication-specific toxicity signals.
**Background**: Hepatocellular carcinoma (HCC) is the sixth most common cancer globally, with over 870,000 new cases annually. Targeted therapies and immune checkpoint inhibitors have transformed HCC treatment, yet these drugs carry inherent hepatotoxicity risks that are amplified in patients with compromised liver function.
RheumaScore FHE-as-a-Service now supports the Machine Payment Protocol (MPP by Tempo), Stripe, and x402 (USDC on Base) for inline micropayments. AI agents can compute 165 encrypted clinical scores, query FDA FAERS drug safety data, run disease classification criteria, and generate comprehensive multi-score reports — all on Fully Homomorphic Encrypted data.
Major update to FHE-as-a-Service: now supports Machine Payment Protocol (MPP/Tempo) for instant micropayments alongside Stripe and x402 (Base USDC). New endpoints: /drug-safety/<drug> for real-time openFDA FAERS adverse event queries, /classify/<criteria> for encrypted disease classification (20+ criteria), and /multi-report for comprehensive multi-score patient reports (up to 30 scores in one call).
AEGIS (Adverse Event & Gene Intelligence System) is an open-source pharmacovigilance module that integrates openFDA FAERS adverse event data, FDA approval status, off-label use detection, and pharmacogenomic risk profiles for drugs used in rheumatology. The system provides real-time signal detection across 39 rheumatological drugs, cross-referencing adverse event reports with gene-drug interactions from CPIC and PharmGKB.