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

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Ledger entry · candidate

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

Drug: ertugliflozin · AE: Urinary tract infection

Discovered via class scan of SGLT2 inhibitors. PRR = 6.46, n = 70 cases.

Disproportionality

PRR: 6.4568014507274105
Yates χ²: n/a
Cases (case-drug + AE): n = 70
Verdict: PASSES_ALL_GATES — PRR=6.46 (95% CI 5.14–8.11), n=70 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: 468a0a006321261952c3b8a3e67f0a69ff7fb561