Ledger entry · null-result

Tirzepatide → Cholelithiasis — Null result

Drug: tirzepatide · AE: Cholelithiasis

Caliper validation of the submitted claim (drug=tirzepatide, AE=Cholelithiasis). BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=1.37, lower CI=1.06)

Disproportionality

PRR: 1.3731742558924345 (95% CI 1.06–1.78)
Yates χ²: 5.411959883289661
Cases (case-drug + AE): n = 57
Verdict: BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=1.37, lower CI=1.06)

Top reactions in cohort

MedDRA PT	n
Cholelithiasis	54
Off label use	13
Pancreatitis	10
Weight decreased	6
Cholecystitis	4
Gallbladder disorder	4
Incorrect dose administered	3
Nausea	3

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