Ledger entry · candidate
Canagliflozin → Diabetic foot infection — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Diabetic foot infection
Discovered via class scan of SGLT2 inhibitors. PRR = 938.95, n = 770 cases.
Disproportionality
- PRR: 938.9487179487179
- Yates χ2: n/a
- Cases (case-drug + AE): n = 770
- Verdict:
PASSES_ALL_GATES — PRR=938.95 (95% CI 845.71–1042.47), n=770 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.