Clozapine → agranulocytosis — Audit-grade candidate

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Ledger entry · candidate

Clozapine → agranulocytosis — Audit-grade candidate

Drug: clozapine · AE: agranulocytosis

Caliper validation of the submitted claim (drug=clozapine, AE=agranulocytosis). PRR = 26.69 (95% CI 24.62–28.92), n = 599 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 26.68581714041004 (95% CI 24.62–28.92)
Yates χ²: 14300.008292452721
Cases (case-drug + AE): n = 599
Verdict: PASSES_ALL_GATES — PRR=26.69 (95% CI 24.62–28.92), n=599 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Agranulocytosis	586
Granulocytopenia	71
White blood cell count decreased	66
Neutropenia	57
Leukopenia	33
White blood cell count increased	29
Thrombocytopenia	28
Mental impairment	27

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: fd01ba4c4ae5c7a8d2030dc957405b56a48ff360