Ledger entry · candidate
Sotagliflozin → Diarrhoea — Audit-grade candidate (class scan)
Drug: sotagliflozin · AE: Diarrhoea
Discovered via class scan of SGLT2 inhibitors. PRR = 2.87, n = 47 cases.
Disproportionality
- PRR: 2.87229021109583
- Yates χ2: n/a
- Cases (case-drug + AE): n = 47
- Verdict:
PASSES_ALL_GATES — PRR=2.87 (95% CI 2.19–3.77), n=47 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.