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.