Ledger entry · null-result
Tirzepatide → Acute kidney injury — Null result
Drug: tirzepatide · AE: Acute kidney injury
Caliper validation of the submitted claim (drug=tirzepatide, AE=Acute kidney injury). BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=0.34, lower CI=0.27)
Disproportionality
- PRR: 0.34418707628811285
(95% CI 0.27–0.44)
- Yates χ2: 82.38764125290685
- Cases (case-drug + AE): n = 66
- Verdict:
BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=0.34, lower CI=0.27)
Top reactions in cohort
| MedDRA PT | n |
|---|
| Acute kidney injury | 64 |
| Dehydration | 23 |
| Diarrhoea | 10 |
| Vomiting | 10 |
| Nausea | 7 |
| Off label use | 7 |
| Septic shock | 4 |
| Weight decreased | 4 |
Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.