Ledger entry · candidate
Empagliflozin → Urinary tract infection — Audit-grade candidate (class scan)
Drug: empagliflozin · AE: Urinary tract infection
Discovered via class scan of SGLT2 inhibitors. PRR = 3.33, n = 748 cases.
Disproportionality
- PRR: 3.3286603105119843
- Yates χ2: n/a
- Cases (case-drug + AE): n = 748
- Verdict:
PASSES_ALL_GATES — PRR=3.33 (95% CI 3.10–3.57), n=748 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.