Ledger entry · candidate
Fezolinetant → Aspartate aminotransferase increased — Audit-grade candidate (scan)
Drug: fezolinetant · AE: Aspartate aminotransferase increased
Discovered via single-drug scan of fezolinetant. PRR = 28.04 (95% CI 23.90–32.90), n = 140 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 28.04358338876568
(95% CI 23.90–32.90)
- Yates χ2: 3623.644053503729
- Cases (case-drug + AE): n = 140
- Verdict:
PASSES_ALL_GATES — PRR=28.04 (95% CI 23.90–32.90), n=140 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.