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

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Ledger entry · candidate

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

Drug: canagliflozin · AE: Toe amputation

Discovered via class scan of SGLT2 inhibitors. PRR = 556.49, n = 2092 cases.

Disproportionality

PRR: 556.4884935009588
Yates χ²: n/a
Cases (case-drug + AE): n = 2092
Verdict: PASSES_ALL_GATES — PRR=556.49 (95% CI 526.74–587.92), n=2092 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: 1f487e80ab5aee7ac1e042013b1fdf89a8cc11fb