Ledger entry · candidate
Dapagliflozin → Dehydration — Audit-grade candidate (class scan)
Drug: dapagliflozin · AE: Dehydration
Discovered via class scan of SGLT2 inhibitors. PRR = 5.05, n = 847 cases.
Disproportionality
- PRR: 5.052383833545268
- Yates χ2: n/a
- Cases (case-drug + AE): n = 847
- Verdict:
PASSES_ALL_GATES — PRR=5.05 (95% CI 4.73–5.40), n=847 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.