Fezolinetant → Liver function test increased — Audit-grade candidate (scan)

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Ledger entry · candidate

Fezolinetant → Liver function test increased — Audit-grade candidate (scan)

Drug: fezolinetant · AE: Liver function test increased

Discovered via single-drug scan of fezolinetant. PRR = 42.41 (95% CI 34.39–52.30), n = 84 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 42.413879731218415 (95% CI 34.39–52.30)
Yates χ²: 3345.160300300249
Cases (case-drug + AE): n = 84
Verdict: PASSES_ALL_GATES — PRR=42.41 (95% CI 34.39–52.30), n=84 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: e32b2fcd3e6651a009e7092b3a7ab4af45fa766f