Ledger entry · candidate
Dapagliflozin → Urinary tract infection — Audit-grade candidate (class scan)
Drug: dapagliflozin · AE: Urinary tract infection
Discovered via class scan of SGLT2 inhibitors. PRR = 3.41, n = 767 cases.
Disproportionality
- PRR: 3.4135875421460598
- Yates χ2: n/a
- Cases (case-drug + AE): n = 767
- Verdict:
PASSES_ALL_GATES — PRR=3.41 (95% CI 3.18–3.66), n=767 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.