Canagliflozin → Gangrene — Audit-grade candidate (class scan)

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Ledger entry · candidate

Canagliflozin → Gangrene — Audit-grade candidate (class scan)

Drug: canagliflozin · AE: Gangrene

Discovered via class scan of SGLT2 inhibitors. PRR = 89.62, n = 1022 cases.

Disproportionality

PRR: 89.61669286084307
Yates χ²: n/a
Cases (case-drug + AE): n = 1022
Verdict: PASSES_ALL_GATES — PRR=89.62 (95% CI 84.09–95.50), n=1022 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: 200ebc899505e144a8fac8196e82905c8226a686