Ledger entry · candidate
Sotagliflozin → Fungal infection — Audit-grade candidate (class scan)
Drug: sotagliflozin · AE: Fungal infection
Discovered via class scan of SGLT2 inhibitors. PRR = 18.13, n = 17 cases.
Disproportionality
- PRR: 18.134954821721568
- Yates χ2: n/a
- Cases (case-drug + AE): n = 17
- Verdict:
PASSES_ALL_GATES — PRR=18.13 (95% CI 11.36–28.95), n=17 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.