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.