Ledger entry · candidate
Dapagliflozin → Acute kidney injury — Audit-grade candidate (class scan)
Drug: dapagliflozin · AE: Acute kidney injury
Discovered via class scan of SGLT2 inhibitors. PRR = 4.12, n = 786 cases.
Disproportionality
- PRR: 4.119087436749263
- Yates χ2: n/a
- Cases (case-drug + AE): n = 786
- Verdict:
PASSES_ALL_GATES — PRR=4.12 (95% CI 3.84–4.41), n=786 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.