Empagliflozin → Euglycaemic diabetic ketoacidosis — Audit-grade candidate (class scan)

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Ledger entry · candidate

Empagliflozin → Euglycaemic diabetic ketoacidosis — Audit-grade candidate (class scan)

Drug: empagliflozin · AE: Euglycaemic diabetic ketoacidosis

Discovered via class scan of SGLT2 inhibitors. PRR = 207.83, n = 807 cases.

Disproportionality

PRR: 207.8317904020217
Yates χ²: n/a
Cases (case-drug + AE): n = 807
Verdict: PASSES_ALL_GATES — PRR=207.83 (95% CI 192.47–224.43), n=807 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: 70bd2500ee4824ca382ca46f08b79311c0ba79ca