Ledger entry · candidate
Varenicline → Feeling abnormal — Audit-grade candidate (scan)
Drug: varenicline · AE: Feeling abnormal
Discovered via single-drug scan of varenicline. PRR = 3.41 (95% CI 3.22–3.62), n = 1038 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 3.414227404902138
(95% CI 3.22–3.62)
- Yates χ2: 1782.6540230131452
- Cases (case-drug + AE): n = 1038
- Verdict:
PASSES_ALL_GATES — PRR=3.41 (95% CI 3.22–3.62), n=1038 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.