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

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Ledger entry · candidate

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

Drug: sotagliflozin · AE: Urinary tract infection

Discovered via class scan of SGLT2 inhibitors. PRR = 5.11, n = 23 cases.

Disproportionality

PRR: 5.112523482374152
Yates χ²: n/a
Cases (case-drug + AE): n = 23
Verdict: PASSES_ALL_GATES — PRR=5.11 (95% CI 3.43–7.62), n=23 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: 87b55d9d699536b92c18d03e6066d10ba53585f5