Fezolinetant → Aspartate aminotransferase increased — Audit-grade candidate (scan)

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Ledger entry · candidate

Fezolinetant → Aspartate aminotransferase increased — Audit-grade candidate (scan)

Drug: fezolinetant · AE: Aspartate aminotransferase increased

Discovered via single-drug scan of fezolinetant. PRR = 28.04 (95% CI 23.90–32.90), n = 140 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 28.04358338876568 (95% CI 23.90–32.90)
Yates χ²: 3623.644053503729
Cases (case-drug + AE): n = 140
Verdict: PASSES_ALL_GATES — PRR=28.04 (95% CI 23.90–32.90), n=140 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: ec5a1153247e2dfcd103144bb30c1d126485717e