Canagliflozin → Urinary tract infection — Audit-grade candidate (class scan)

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Ledger entry · candidate

Canagliflozin → Urinary tract infection — Audit-grade candidate (class scan)

Drug: canagliflozin · AE: Urinary tract infection

Discovered via class scan of SGLT2 inhibitors. PRR = 4.13, n = 927 cases.

Disproportionality

PRR: 4.129506552918014
Yates χ²: n/a
Cases (case-drug + AE): n = 927
Verdict: PASSES_ALL_GATES — PRR=4.13 (95% CI 3.88–4.40), n=927 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: 2afbf2faffc15ad6b0bffd36d3122e8fb3c39c21