Ledger entry · candidate
Empagliflozin → Fungal infection — Audit-grade candidate (class scan)
Drug: empagliflozin · AE: Fungal infection
Discovered via class scan of SGLT2 inhibitors. PRR = 25.82, n = 1175 cases.
Disproportionality
- PRR: 25.816420816420816
- Yates χ2: n/a
- Cases (case-drug + AE): n = 1175
- Verdict:
PASSES_ALL_GATES — PRR=25.82 (95% CI 24.39–27.33), n=1175 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.