Ledger entry · candidate
Sotagliflozin → Therapy interrupted — Audit-grade candidate (class scan)
Drug: sotagliflozin · AE: Therapy interrupted
Discovered via class scan of SGLT2 inhibitors. PRR = 19.71, n = 33 cases.
Disproportionality
- PRR: 19.709594082022885
- Yates χ2: n/a
- Cases (case-drug + AE): n = 33
- Verdict:
PASSES_ALL_GATES — PRR=19.71 (95% CI 14.17–27.42), n=33 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.