Ledger entry · null-result

Adagrasib → Hepatotoxicity — Null result

Drug: adagrasib · AE: Hepatotoxicity

Caliper validation of the submitted claim (drug=adagrasib, AE=Hepatotoxicity). BELOW_DEDUP_THRESHOLD — only 4 unique cases after dedup; insufficient signal density

Disproportionality

PRR: 3.7572675039840764 (95% CI 1.41–9.99)
Yates χ²: 5.5760470755293285
Cases (case-drug + AE): n = 4
Verdict: BELOW_DEDUP_THRESHOLD — only 4 unique cases after dedup; insufficient signal density

Top reactions in cohort

MedDRA PT	n
Hepatotoxicity	4
Alanine aminotransferase increased	1
Aspartate aminotransferase increased	1
Blood alkaline phosphatase increased	1
Gamma-glutamyltransferase increased	1
Hypoxia	1
Lung consolidation	1
Neoplasm progression	1

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