Ledger entry · null-result

Tirzepatide → Diarrhoea — Null result

Drug: tirzepatide · AE: Diarrhoea

Caliper validation of the submitted claim (drug=tirzepatide, AE=Diarrhoea). BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=1.70, lower CI=1.61)

Disproportionality

PRR: 1.6959033106193178 (95% CI 1.61–1.79)
Yates χ²: 407.9357060657337
Cases (case-drug + AE): n = 1389
Verdict: BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=1.70, lower CI=1.61)

Top reactions in cohort

MedDRA PT	n
Diarrhoea	1351
Nausea	496
Vomiting	369
Off label use	201
Eructation	178
Abdominal pain upper	160
Constipation	129
Decreased appetite	105

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