Metformin → lactic acidosis — Audit-grade candidate

Drug: metformin · AE: lactic acidosis

Caliper validation of the submitted claim (drug=metformin, AE=lactic acidosis). PRR = 15.61 (95% CI 14.43–16.90), n = 614 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

• PRR: 15.612275917905944 (95% CI 14.43–16.90)
• Yates χ²: 8228.3611811498
• Cases (case-drug + AE): n = 614
• Verdict: PASSES_ALL_GATES — PRR=15.61 (95% CI 14.43–16.90), n=614 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.