Ledger entry · candidate
Fezolinetant → Liver function test increased — Audit-grade candidate (scan)
Drug: fezolinetant · AE: Liver function test increased
Discovered via single-drug scan of fezolinetant. PRR = 42.41 (95% CI 34.39–52.30), n = 84 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 42.413879731218415
(95% CI 34.39–52.30)
- Yates χ2: 3345.160300300249
- Cases (case-drug + AE): n = 84
- Verdict:
PASSES_ALL_GATES — PRR=42.41 (95% CI 34.39–52.30), n=84 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.