Clozapine → Mental impairment — Audit-grade candidate (scan)

Drug: clozapine · AE: Mental impairment

Discovered via single-drug scan of clozapine. PRR = 18.91 (95% CI 17.42–20.53), n = 569 cases. Pre-reg locked at submission time.

Disproportionality

• PRR: 18.912443546588833 (95% CI 17.42–20.53)
• Yates χ²: 9414.981968365477
• Cases (case-drug + AE): n = 569
• Verdict: PASSES_ALL_GATES — PRR=18.91 (95% CI 17.42–20.53), n=569 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.