Ledger entry · candidate

Remdesivir → Acute kidney injury — Audit-grade candidate

Drug: remdesivir · AE: Acute kidney injury

Caliper validation of the submitted claim (drug=remdesivir, AE=Acute kidney injury). PRR = 6.45 (95% CI 5.97–6.96), n = 624 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 6.449393913834938 (95% CI 5.97–6.96)
Yates χ²: 2876.781646648046
Cases (case-drug + AE): n = 624
Verdict: PASSES_ALL_GATES — PRR=6.45 (95% CI 5.97–6.96), n=624 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Acute kidney injury	539
Blood creatinine increased	57
Septic shock	47
Hypotension	40
Respiratory failure	40
COVID-19	33
Sepsis	32
Multiple organ dysfunction syndrome	30

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