Ledger entry · candidate
Canagliflozin → Acute kidney injury — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Acute kidney injury
Discovered via class scan of SGLT2 inhibitors. PRR = 9.83, n = 1862 cases.
Disproportionality
- PRR: 9.830093338288256
- Yates χ2: n/a
- Cases (case-drug + AE): n = 1862
- Verdict:
PASSES_ALL_GATES — PRR=9.83 (95% CI 9.41–10.27), n=1862 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.