Ledger entry · candidate
Varenicline → Anxiety — Audit-grade candidate (scan)
Drug: varenicline · AE: Anxiety
Discovered via single-drug scan of varenicline. PRR = 2.80 (95% CI 2.63–2.97), n = 1030 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 2.7950663456036153
(95% CI 2.63–2.97)
- Yates χ2: 1198.3543204145435
- Cases (case-drug + AE): n = 1030
- Verdict:
PASSES_ALL_GATES — PRR=2.80 (95% CI 2.63–2.97), n=1030 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.