Ledger entry · candidate
Empagliflozin → Pollakiuria — Audit-grade candidate (class scan)
Drug: empagliflozin · AE: Pollakiuria
Discovered via class scan of SGLT2 inhibitors. PRR = 13.85, n = 715 cases.
Disproportionality
- PRR: 13.851245713132943
- Yates χ2: n/a
- Cases (case-drug + AE): n = 715
- Verdict:
PASSES_ALL_GATES — PRR=13.85 (95% CI 12.88–14.90), n=715 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.