Rosiglitazone → Myocardial infarction — Audit-grade candidate

Drug: rosiglitazone · AE: Myocardial infarction · vs pioglitazone

Caliper validation of the submitted claim (drug=rosiglitazone, AE=Myocardial infarction, comparator=pioglitazone). PRR = 20.93 (95% CI 19.72–22.21), n = 863 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

• PRR: 20.927150295465278 (95% CI 19.72–22.21)
• Yates χ²: 16450.385802908935
• Cases (case-drug + AE): n = 863
• Verdict: PASSES_ALL_GATES — PRR=20.93 (95% CI 19.72–22.21), n=863 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.