Ledger entry · candidate
Dapagliflozin → Diabetic ketoacidosis — Audit-grade candidate (class scan)
Drug: dapagliflozin · AE: Diabetic ketoacidosis
Discovered via class scan of SGLT2 inhibitors. PRR = 40.64, n = 1359 cases.
Disproportionality
- PRR: 40.63779593572128
- Yates χ2: n/a
- Cases (case-drug + AE): n = 1359
- Verdict:
PASSES_ALL_GATES — PRR=40.64 (95% CI 38.53–42.86), n=1359 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.