Ledger entry · candidate
Canagliflozin → Renal failure — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Renal failure
Discovered via class scan of SGLT2 inhibitors. PRR = 2.81, n = 653 cases.
Disproportionality
- PRR: 2.809493283980423
- Yates χ2: n/a
- Cases (case-drug + AE): n = 653
- Verdict:
PASSES_ALL_GATES — PRR=2.81 (95% CI 2.60–3.03), n=653 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.