Ledger entry · candidate
Varenicline → Insomnia — Audit-grade candidate (scan)
Drug: varenicline · AE: Insomnia
Discovered via single-drug scan of varenicline. PRR = 2.74 (95% CI 2.58–2.91), n = 1030 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 2.7414949669393076
(95% CI 2.58–2.91)
- Yates χ2: 1150.3186515888035
- Cases (case-drug + AE): n = 1030
- Verdict:
PASSES_ALL_GATES — PRR=2.74 (95% CI 2.58–2.91), 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.