Ozanimod → Macular oedema — Audit-grade candidate

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Ledger entry · candidate

Ozanimod → Macular oedema — Audit-grade candidate

Drug: ozanimod · AE: Macular oedema

Caliper validation of the submitted claim (drug=ozanimod, AE=Macular oedema). PRR = 9.70 (95% CI 6.70–14.05), n = 28 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 9.699562079057959 (95% CI 6.70–14.05)
Yates χ²: 209.11699454124025
Cases (case-drug + AE): n = 28
Verdict: PASSES_ALL_GATES — PRR=9.70 (95% CI 6.70–14.05), n=28 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Macular oedema	28
Cataract	3
Drug ineffective	2
Headache	2
Vision blurred	2
Amnesia	1
Asthenia	1
Back pain	1

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: f61184498d0258451d3ceab141cd95a7e7b132e9