Fezolinetant → Gamma-glutamyltransferase increased — Audit-grade candidate (scan)

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Ledger entry · candidate

Fezolinetant → Gamma-glutamyltransferase increased — Audit-grade candidate (scan)

Drug: fezolinetant · AE: Gamma-glutamyltransferase increased

Discovered via single-drug scan of fezolinetant. PRR = 18.65 (95% CI 13.66–25.45), n = 39 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 18.648768642415323 (95% CI 13.66–25.45)
Yates χ²: 633.4044970087722
Cases (case-drug + AE): n = 39
Verdict: PASSES_ALL_GATES — PRR=18.65 (95% CI 13.66–25.45), n=39 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: 691ce541272c2df1b82b9e03565c42f1143b9160