Varenicline → Drug hypersensitivity — Audit-grade candidate (scan)

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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.

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Reference: d2c92b28415ea4d5f73bae9659a85a692740ef2e