Ledger entry · candidate
Varenicline → Drug hypersensitivity — Audit-grade candidate (scan)
Drug: varenicline · AE: Drug hypersensitivity
Discovered via single-drug scan of varenicline. PRR = 3.20 (95% CI 2.99–3.43), n = 787 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 3.1994031675836387
(95% CI 2.99–3.43)
- Yates χ2: 1194.1162615565054
- Cases (case-drug + AE): n = 787
- Verdict:
PASSES_ALL_GATES — PRR=3.20 (95% CI 2.99–3.43), n=787 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.