Metformin → lactic acidosis — Audit-grade candidate

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Ledger entry · candidate

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

MedDRA PT	n
Lactic acidosis	586
Acute kidney injury	140
Renal failure acute	93
Diarrhoea	92
Vomiting	89
Toxicity to various agents	76
Hypoglycaemia	69
Intentional overdose	66

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

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Reference: c15768cc5d12ad025d03f309bfcc3bff3fd37b27