Fezolinetant → Abdominal pain upper — Audit-grade candidate (scan)

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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.

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Reference: 1856dd1b8799e104312d8a0afb580f896b3615b0