Ledger entry · candidate
Ertugliflozin → Urinary tract infection — Audit-grade candidate (class scan)
Drug: ertugliflozin · AE: Urinary tract infection
Discovered via class scan of SGLT2 inhibitors. PRR = 6.46, n = 70 cases.
Disproportionality
- PRR: 6.4568014507274105
- Yates χ2: n/a
- Cases (case-drug + AE): n = 70
- Verdict:
PASSES_ALL_GATES — PRR=6.46 (95% CI 5.14–8.11), n=70 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.