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.