Ledger entry · candidate
Clozapine → Agranulocytosis — Audit-grade candidate (scan)
Drug: clozapine · AE: Agranulocytosis
Discovered via single-drug scan of clozapine. PRR = 26.69 (95% CI 24.62–28.93), n = 599 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 26.687364772326788
(95% CI 24.62–28.93)
- Yates χ2: 14300.8736873132
- Cases (case-drug + AE): n = 599
- Verdict:
PASSES_ALL_GATES — PRR=26.69 (95% CI 24.62–28.93), n=599 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.