Ledger entry · candidate
Ertugliflozin → Diabetic ketoacidosis — Audit-grade candidate (class scan)
Drug: ertugliflozin · AE: Diabetic ketoacidosis
Discovered via class scan of SGLT2 inhibitors. PRR = 34.94, n = 59 cases.
Disproportionality
- PRR: 34.94447792512535
- Yates χ2: n/a
- Cases (case-drug + AE): n = 59
- Verdict:
PASSES_ALL_GATES — PRR=34.94 (95% CI 27.23–44.84), n=59 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.