Ledger entry · candidate
Canagliflozin → Urinary tract infection — Audit-grade candidate (class scan)
Drug: canagliflozin · AE: Urinary tract infection
Discovered via class scan of SGLT2 inhibitors. PRR = 4.13, n = 927 cases.
Disproportionality
- PRR: 4.129506552918014
- Yates χ2: n/a
- Cases (case-drug + AE): n = 927
- Verdict:
PASSES_ALL_GATES — PRR=4.13 (95% CI 3.88–4.40), n=927 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.