Fezolinetant → Alanine aminotransferase increased — Audit-grade candidate

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Ledger entry · candidate

Fezolinetant → Alanine aminotransferase increased — Audit-grade candidate

Drug: fezolinetant · AE: Alanine aminotransferase increased

Caliper validation of the submitted claim (drug=fezolinetant, AE=Alanine aminotransferase increased). PRR = 31.71 (95% CI 27.62–36.41), n = 183 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 31.714118173986254 (95% CI 27.62–36.41)
Yates χ²: 5412.375420293019
Cases (case-drug + AE): n = 183
Verdict: PASSES_ALL_GATES — PRR=31.71 (95% CI 27.62–36.41), n=183 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Alanine aminotransferase increased	182
Aspartate aminotransferase increased	124
Gamma-glutamyltransferase increased	20
Blood alkaline phosphatase increased	19
Blood bilirubin increased	10
Abdominal pain	5
Drug ineffective	5
Fatigue	5

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: 3d3139051809438924da4dac3cdbb82f81f86fee