Ledger entry · candidate
Canagliflozin → Diabetic ketoacidosis — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Diabetic ketoacidosis
Discovered via class scan of SGLT2 inhibitors. PRR = 104.61, n = 3242 cases.
Disproportionality
- PRR: 104.61206963399503
- Yates χ2: n/a
- Cases (case-drug + AE): n = 3242
- Verdict:
PASSES_ALL_GATES — PRR=104.61 (95% CI 101.05–108.30), n=3242 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.