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

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Ledger entry · candidate

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

Drug: dapagliflozin · AE: Fungal infection

Discovered via class scan of SGLT2 inhibitors. PRR = 24.77, n = 1129 cases.

Disproportionality

PRR: 24.773143825127487
Yates χ²: n/a
Cases (case-drug + AE): n = 1129
Verdict: PASSES_ALL_GATES — PRR=24.77 (95% CI 23.38–26.25), n=1129 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: 7a65d7e1b4fdb202a30f10019f6bf5b9be6aaad4