Ledger entry · candidate
Ertugliflozin → Diabetes mellitus inadequate control — Audit-grade candidate (class scan)
Drug: ertugliflozin · AE: Diabetes mellitus inadequate control
Discovered via class scan of SGLT2 inhibitors. PRR = 26.14, n = 28 cases.
Disproportionality
- PRR: 26.13803716734642
- Yates χ2: n/a
- Cases (case-drug + AE): n = 28
- Verdict:
PASSES_ALL_GATES — PRR=26.14 (95% CI 18.12–37.71), n=28 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.