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.