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.