Empagliflozin → Ketoacidosis — Audit-grade candidate (class scan)

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Ledger entry · candidate

Empagliflozin → Ketoacidosis — Audit-grade candidate (class scan)

Drug: empagliflozin · AE: Ketoacidosis

Discovered via class scan of SGLT2 inhibitors. PRR = 23.71, n = 1029 cases.

Disproportionality

PRR: 23.711252933155208
Yates χ²: n/a
Cases (case-drug + AE): n = 1029
Verdict: PASSES_ALL_GATES — PRR=23.71 (95% CI 22.31–25.20), n=1029 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
No reactions surfaced in cohort.

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: b8194fbf636a222dac0fbfe7f7366632657bca36