Fezolinetant → Night sweats — Audit-grade candidate (scan)

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Ledger entry · candidate

Fezolinetant → Night sweats — Audit-grade candidate (scan)

Drug: fezolinetant · AE: Night sweats

Discovered via single-drug scan of fezolinetant. PRR = 11.25 (95% CI 8.06–15.70), n = 34 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 11.250058894799015 (95% CI 8.06–15.70)
Yates χ²: 307.5015970630344
Cases (case-drug + AE): n = 34
Verdict: PASSES_ALL_GATES — PRR=11.25 (95% CI 8.06–15.70), n=34 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: b90bf4bb1550e6be58540760138d1dff68e308c6