Ledger entry · candidate
Canagliflozin → Diabetic foot — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Diabetic foot
Discovered via class scan of SGLT2 inhibitors. PRR = 164.03, n = 749 cases.
Disproportionality
- PRR: 164.026466976581
- Yates χ2: n/a
- Cases (case-drug + AE): n = 749
- Verdict:
PASSES_ALL_GATES — PRR=164.03 (95% CI 151.73–177.32), n=749 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.