Canagliflozin → Renal failure — Audit-grade candidate (class scan)

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Ledger entry · candidate

Canagliflozin → Renal failure — Audit-grade candidate (class scan)

Drug: canagliflozin · AE: Renal failure

Discovered via class scan of SGLT2 inhibitors. PRR = 2.81, n = 653 cases.

Disproportionality

PRR: 2.809493283980423
Yates χ²: n/a
Cases (case-drug + AE): n = 653
Verdict: PASSES_ALL_GATES — PRR=2.81 (95% CI 2.60–3.03), n=653 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
No reactions surfaced in cohort.

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

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Reference: 523c6429bb1032328af90e69e6d2f8d30026e9f3