Ledger entry · candidate
Ertugliflozin → No adverse event — Audit-grade candidate (class scan)
Drug: ertugliflozin · AE: No adverse event
Discovered via class scan of SGLT2 inhibitors. PRR = 6.44, n = 69 cases.
Disproportionality
- PRR: 6.439655006101955
- Yates χ2: n/a
- Cases (case-drug + AE): n = 69
- Verdict:
PASSES_ALL_GATES — PRR=6.44 (95% CI 5.12–8.10), n=69 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.