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

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Ledger entry · candidate

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

Drug: dapagliflozin · AE: Urinary tract infection

Discovered via class scan of SGLT2 inhibitors. PRR = 3.41, n = 767 cases.

Disproportionality

PRR: 3.4135875421460598
Yates χ²: n/a
Cases (case-drug + AE): n = 767
Verdict: PASSES_ALL_GATES — PRR=3.41 (95% CI 3.18–3.66), n=767 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: 7c7b5c3e04e827ea1c4cb152d282ddedbd408158