Ledger entry · candidate

Fezolinetant → Hepatic enzyme increased — Audit-grade candidate

Drug: fezolinetant · AE: Hepatic enzyme increased

Caliper validation of the submitted claim (drug=fezolinetant, AE=Hepatic enzyme increased). PRR = 27.01 (95% CI 23.41–31.15), n = 172 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

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
Hepatic enzyme increased	171
Fatigue	8
Abdominal pain	5
Off label use	5
Drug ineffective	4
Nausea	4
Abdominal pain upper	3
Alanine aminotransferase increased	3

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.