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.