Ledger entry · candidate
Sotagliflozin → Urinary tract infection — Audit-grade candidate (class scan)
Drug: sotagliflozin · AE: Urinary tract infection
Discovered via class scan of SGLT2 inhibitors. PRR = 5.11, n = 23 cases.
Disproportionality
- PRR: 5.112523482374152
- Yates χ2: n/a
- Cases (case-drug + AE): n = 23
- Verdict:
PASSES_ALL_GATES — PRR=5.11 (95% CI 3.43–7.62), n=23 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.