Ledger entry · candidate
Fezolinetant → Alanine aminotransferase increased — Audit-grade candidate (scan)
Drug: fezolinetant · AE: Alanine aminotransferase increased
Discovered via single-drug scan of fezolinetant. PRR = 31.71 (95% CI 27.62–36.41), n = 183 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 31.714118173986254
(95% CI 27.62–36.41)
- Yates χ2: 5412.375420293019
- Cases (case-drug + AE): n = 183
- Verdict:
PASSES_ALL_GATES — PRR=31.71 (95% CI 27.62–36.41), n=183 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.