Ledger entry · candidate

Tirzepatide → Vomiting — Audit-grade candidate

Drug: tirzepatide · AE: Vomiting

Caliper validation of the submitted claim (drug=tirzepatide, AE=Vomiting). PRR = 2.00 (95% CI 1.90–2.12), n = 1194 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 2.003664387906243 (95% CI 1.90–2.12)
Yates χ²: 611.759507907894
Cases (case-drug + AE): n = 1194
Verdict: PASSES_ALL_GATES — PRR=2.00 (95% CI 1.90–2.12), n=1194 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Vomiting	1157
Nausea	684
Diarrhoea	369
Off label use	178
Abdominal pain upper	120
Dehydration	92
Constipation	88
Decreased appetite	83

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.