Clozapine → Constipation — Audit-grade candidate (scan)

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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.

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Reference: 1c944e46b1bd508e3f13e8669ee70d38295bcee1