Varenicline → Nausea — Audit-grade candidate (scan)

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Ledger entry · candidate

Varenicline → Nausea — Audit-grade candidate (scan)

Drug: varenicline · AE: Nausea

Discovered via single-drug scan of varenicline. PRR = 2.92 (95% CI 2.82–3.02), n = 2892 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 2.9165890623684083 (95% CI 2.82–3.02)
Yates χ²: 3770.8246680813604
Cases (case-drug + AE): n = 2892
Verdict: PASSES_ALL_GATES — PRR=2.92 (95% CI 2.82–3.02), n=2892 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: f6bb8fb74939496e9bcc636739f300ec943ca528