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

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Ledger entry · candidate

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

Drug: sotagliflozin · AE: Fungal infection

Discovered via class scan of SGLT2 inhibitors. PRR = 18.13, n = 17 cases.

Disproportionality

PRR: 18.134954821721568
Yates χ²: n/a
Cases (case-drug + AE): n = 17
Verdict: PASSES_ALL_GATES — PRR=18.13 (95% CI 11.36–28.95), n=17 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: 5c5a61a6827cb79364c1a7cb6489ed36e73e5889