Ledger entry · candidate
Varenicline → Suicidal ideation — Audit-grade candidate (scan)
Drug: varenicline · AE: Suicidal ideation
Discovered via single-drug scan of varenicline. PRR = 5.37 (95% CI 4.96–5.80), n = 619 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 5.365212123631673
(95% CI 4.96–5.80)
- Yates χ2: 2188.620608250207
- Cases (case-drug + AE): n = 619
- Verdict:
PASSES_ALL_GATES — PRR=5.37 (95% CI 4.96–5.80), n=619 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.