Clozapine → White blood cell count increased — Audit-grade candidate (scan)

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Ledger entry · candidate

Clozapine → White blood cell count increased — Audit-grade candidate (scan)

Drug: clozapine · AE: White blood cell count increased

Discovered via single-drug scan of clozapine. PRR = 35.18 (95% CI 33.54–36.90), n = 1653 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 35.17980612068764 (95% CI 33.54–36.90)
Yates χ²: 52556.01750592199
Cases (case-drug + AE): n = 1653
Verdict: PASSES_ALL_GATES — PRR=35.18 (95% CI 33.54–36.90), n=1653 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: 7b6c3a97c799179398228a460eae5f4d38243b08