Ledger entry · candidate
Sotagliflozin → Abdominal discomfort — Audit-grade candidate (class scan)
Drug: sotagliflozin · AE: Abdominal discomfort
Discovered via class scan of SGLT2 inhibitors. PRR = 2.62, n = 11 cases.
Disproportionality
- PRR: 2.619525264452701
- Yates χ2: n/a
- Cases (case-drug + AE): n = 11
- Verdict:
PASSES_ALL_GATES — PRR=2.62 (95% CI 1.46–4.70), n=11 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.