Inclisiran → Injection site reaction — Audit-grade candidate

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Ledger entry · candidate

Inclisiran → Injection site reaction — Audit-grade candidate

Drug: inclisiran · AE: Injection site reaction

Caliper validation of the submitted claim (drug=inclisiran, AE=Injection site reaction). PRR = 8.10 (95% CI 7.07–9.29), n = 201 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 8.102680814677688 (95% CI 7.07–9.29)
Yates χ²: 1244.7208786284455
Cases (case-drug + AE): n = 201
Verdict: PASSES_ALL_GATES — PRR=8.10 (95% CI 7.07–9.29), n=201 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Injection site reaction	201
Injection site erythema	24
Injection site pain	16
Arthralgia	15
Injection site pruritus	13
Fatigue	11
Injection site rash	10
Injection site swelling	10

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: c816fe79e82f765c618a298ea8b592dda2bce40f