Ledger entry · candidate
Fezolinetant → Gamma-glutamyltransferase increased — Audit-grade candidate (scan)
Drug: fezolinetant · AE: Gamma-glutamyltransferase increased
Discovered via single-drug scan of fezolinetant. PRR = 18.65 (95% CI 13.66–25.45), n = 39 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 18.648768642415323
(95% CI 13.66–25.45)
- Yates χ2: 633.4044970087722
- Cases (case-drug + AE): n = 39
- Verdict:
PASSES_ALL_GATES — PRR=18.65 (95% CI 13.66–25.45), n=39 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.