Ledger entry · candidate
Fezolinetant → Abdominal pain upper — Audit-grade candidate (scan)
Drug: fezolinetant · AE: Abdominal pain upper
Discovered via single-drug scan of fezolinetant. PRR = 2.29 (95% CI 1.71–3.06), n = 44 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 2.2850212265533534
(95% CI 1.71–3.06)
- Yates χ2: 30.824322770458714
- Cases (case-drug + AE): n = 44
- Verdict:
PASSES_ALL_GATES — PRR=2.29 (95% CI 1.71–3.06), n=44 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.