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

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Ledger entry · candidate

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

Drug: ertugliflozin · AE: Fungal infection

Discovered via class scan of SGLT2 inhibitors. PRR = 27.92, n = 63 cases.

Disproportionality

PRR: 27.916158344771365
Yates χ²: n/a
Cases (case-drug + AE): n = 63
Verdict: PASSES_ALL_GATES — PRR=27.92 (95% CI 21.94–35.52), n=63 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: 05a1e4f96953d382356e8b0fe11572bddad1e66c