Ledger entry · candidate

Empagliflozin → acute kidney injury — Audit-grade candidate

Drug: empagliflozin · AE: acute kidney injury

Caliper validation of the submitted claim (drug=empagliflozin, AE=acute kidney injury). PRR = 3.05 (95% CI 2.82–3.31), n = 583 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 3.0510268567368217 (95% CI 2.82–3.31)
Yates χ²: 804.5364000143675
Cases (case-drug + AE): n = 583
Verdict: PASSES_ALL_GATES — PRR=3.05 (95% CI 2.82–3.31), n=583 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Acute kidney injury	429
Diabetic ketoacidosis	79
Dehydration	50
Vomiting	50
Metabolic acidosis	47
Nausea	40
Hyperglycaemia	38
Ketoacidosis	29

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