Fezolinetant → Hepatic enzyme increased — Audit-grade candidate (scan)

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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.

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Reference: c2c8b3c9b8d736f1910f0fef9b472fc5f1d3f963