Ledger entry · candidate
Varenicline → Depression — Audit-grade candidate (scan)
Drug: varenicline · AE: Depression
Discovered via single-drug scan of varenicline. PRR = 3.53 (95% CI 3.34–3.74), n = 1139 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 3.5320313322347734
(95% CI 3.34–3.74)
- Yates χ2: 2081.3763960780357
- Cases (case-drug + AE): n = 1139
- Verdict:
PASSES_ALL_GATES — PRR=3.53 (95% CI 3.34–3.74), n=1139 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.