Ledger entry · candidate
Canagliflozin → Leg amputation — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Leg amputation
Discovered via class scan of SGLT2 inhibitors. PRR = 169.87, n = 731 cases.
Disproportionality
- PRR: 169.8659081390479
- Yates χ2: n/a
- Cases (case-drug + AE): n = 731
- Verdict:
PASSES_ALL_GATES — PRR=169.87 (95% CI 156.93–183.86), n=731 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.