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.