Varenicline → Depression — Audit-grade candidate (scan)

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Ledger entry · candidate

Varenicline → Depression — Audit-grade candidate (scan)

Drug: varenicline · AE: Depression

Discovered via single-drug scan of varenicline. PRR = 3.53 (95% CI 3.34–3.74), n = 1139 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 3.5320313322347734 (95% CI 3.34–3.74)
Yates χ²: 2081.3763960780357
Cases (case-drug + AE): n = 1139
Verdict: PASSES_ALL_GATES — PRR=3.53 (95% CI 3.34–3.74), n=1139 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: d349607759b05757d4ac5eba9a053ecf8e6eed4f