Ledger entry · candidate
Fezolinetant → Hepatic enzyme increased — Audit-grade candidate (scan)
Drug: fezolinetant · AE: Hepatic enzyme increased
Discovered via single-drug scan of fezolinetant. PRR = 27.01 (95% CI 23.41–31.15), n = 172 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 27.00626849509904
(95% CI 23.41–31.15)
- Yates χ2: 4284.429998683399
- Cases (case-drug + AE): n = 172
- Verdict:
PASSES_ALL_GATES — PRR=27.01 (95% CI 23.41–31.15), n=172 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.