Tirzepatide → Nausea — Audit-grade candidate

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Ledger entry · candidate

Tirzepatide → Nausea — Audit-grade candidate

Drug: tirzepatide · AE: Nausea

Caliper validation of the submitted claim (drug=tirzepatide, AE=Nausea). PRR = 3.15 (95% CI 3.05–3.26), n = 3124 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 3.151575257911493 (95% CI 3.05–3.26)
Yates χ²: 4749.457737837254
Cases (case-drug + AE): n = 3124
Verdict: PASSES_ALL_GATES — PRR=3.15 (95% CI 3.05–3.26), n=3124 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Nausea	3055
Vomiting	684
Off label use	567
Diarrhoea	496
Decreased appetite	341
Constipation	263
Incorrect dose administered	262
Headache	221

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: 5ad9eec52dc8e98add29aa62f961189a930efb3b