Ledger entry · candidate
Canagliflozin → Gangrene — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Gangrene
Discovered via class scan of SGLT2 inhibitors. PRR = 89.62, n = 1022 cases.
Disproportionality
- PRR: 89.61669286084307
- Yates χ2: n/a
- Cases (case-drug + AE): n = 1022
- Verdict:
PASSES_ALL_GATES — PRR=89.62 (95% CI 84.09–95.50), n=1022 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.