Clozapine → Haemoglobin decreased — Audit-grade candidate (scan)

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Ledger entry · candidate

Clozapine → Haemoglobin decreased — Audit-grade candidate (scan)

Drug: clozapine · AE: Haemoglobin decreased

Discovered via single-drug scan of clozapine. PRR = 5.21 (95% CI 4.84–5.61), n = 691 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 5.207552252726771 (95% CI 4.84–5.61)
Yates χ²: 2341.124546157278
Cases (case-drug + AE): n = 691
Verdict: PASSES_ALL_GATES — PRR=5.21 (95% CI 4.84–5.61), n=691 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: f74c0a3edbd30193bb47e7fb7ecb7b632dd83214