Varenicline → Nightmare — Audit-grade candidate (scan)

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Ledger entry · candidate

Varenicline → Nightmare — Audit-grade candidate (scan)

Drug: varenicline · AE: Nightmare

Discovered via single-drug scan of varenicline. PRR = 24.24 (95% CI 22.81–25.75), n = 1037 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 24.24023452585753 (95% CI 22.81–25.75)
Yates χ²: 22414.578060197033
Cases (case-drug + AE): n = 1037
Verdict: PASSES_ALL_GATES — PRR=24.24 (95% CI 22.81–25.75), n=1037 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: 7ea82f1cdaf6bd36f19861c1608d240883975ce4