Clozapine → Psychotic disorder — Audit-grade candidate (scan)

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Ledger entry · candidate

Clozapine → Psychotic disorder — Audit-grade candidate (scan)

Drug: clozapine · AE: Psychotic disorder

Discovered via single-drug scan of clozapine. PRR = 18.79 (95% CI 17.49–20.18), n = 748 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 18.790027316219195 (95% CI 17.49–20.18)
Yates χ²: 12299.841114593335
Cases (case-drug + AE): n = 748
Verdict: PASSES_ALL_GATES — PRR=18.79 (95% CI 17.49–20.18), n=748 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: b7f29a0a76c4cec3c481a157c46e4b733233223f