Fezolinetant → Hot flush — Audit-grade candidate (scan)

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Ledger entry · candidate

Fezolinetant → Hot flush — Audit-grade candidate (scan)

Drug: fezolinetant · AE: Hot flush

Discovered via single-drug scan of fezolinetant. PRR = 13.51 (95% CI 11.12–16.43), n = 96 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 13.51359422929403 (95% CI 11.12–16.43)
Yates χ²: 1102.5400318494524
Cases (case-drug + AE): n = 96
Verdict: PASSES_ALL_GATES — PRR=13.51 (95% CI 11.12–16.43), n=96 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: 52e950e6464aab75332e66de2c0ced9a583566f4