Ledger entry · candidate
Varenicline → Malaise — Audit-grade candidate (scan)
Drug: varenicline · AE: Malaise
Discovered via single-drug scan of varenicline. PRR = 2.12 (95% CI 2.00–2.24), n = 1177 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 2.1172549802246383
(95% CI 2.00–2.24)
- Yates χ2: 706.0124619774072
- Cases (case-drug + AE): n = 1177
- Verdict:
PASSES_ALL_GATES — PRR=2.12 (95% CI 2.00–2.24), n=1177 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.