Ledger entry · candidate
Sotagliflozin → Product use issue — Audit-grade candidate (class scan)
Drug: sotagliflozin · AE: Product use issue
Discovered via class scan of SGLT2 inhibitors. PRR = 3.39, n = 23 cases.
Disproportionality
- PRR: 3.39190061101661
- Yates χ2: n/a
- Cases (case-drug + AE): n = 23
- Verdict:
PASSES_ALL_GATES — PRR=3.39 (95% CI 2.27–5.06), 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.