Varenicline → Suicidal ideation — Audit-grade candidate (scan)

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Ledger entry · candidate

Varenicline → Suicidal ideation — Audit-grade candidate (scan)

Drug: varenicline · AE: Suicidal ideation

Discovered via single-drug scan of varenicline. PRR = 5.37 (95% CI 4.96–5.80), n = 619 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 5.365212123631673 (95% CI 4.96–5.80)
Yates χ²: 2188.620608250207
Cases (case-drug + AE): n = 619
Verdict: PASSES_ALL_GATES — PRR=5.37 (95% CI 4.96–5.80), n=619 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: 32f5721549fc7a1aa103f7f3dee8ebdd8586329d