Canagliflozin → Leg amputation — Audit-grade candidate (class scan)

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Ledger entry · candidate

Canagliflozin → Leg amputation — Audit-grade candidate (class scan)

Drug: canagliflozin · AE: Leg amputation

Discovered via class scan of SGLT2 inhibitors. PRR = 169.87, n = 731 cases.

Disproportionality

PRR: 169.8659081390479
Yates χ²: n/a
Cases (case-drug + AE): n = 731
Verdict: PASSES_ALL_GATES — PRR=169.87 (95% CI 156.93–183.86), n=731 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: b51e7a901005c3bb7cfba43d1c030554303dba28