Ledger entry · candidate
Clozapine → Constipation — Audit-grade candidate (scan)
Drug: clozapine · AE: Constipation
Discovered via single-drug scan of clozapine. PRR = 2.02 (95% CI 1.86–2.19), n = 546 cases. Pre-reg locked at submission time.
Disproportionality
- PRR: 2.016964556195093
(95% CI 1.86–2.19)
- Yates χ2: 281.14975910826337
- Cases (case-drug + AE): n = 546
- Verdict:
PASSES_ALL_GATES — PRR=2.02 (95% CI 1.86–2.19), n=546 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.