Dapagliflozin → Diabetic ketoacidosis — Audit-grade candidate (class scan)

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Ledger entry · candidate

Dapagliflozin → Diabetic ketoacidosis — Audit-grade candidate (class scan)

Drug: dapagliflozin · AE: Diabetic ketoacidosis

Discovered via class scan of SGLT2 inhibitors. PRR = 40.64, n = 1359 cases.

Disproportionality

PRR: 40.63779593572128
Yates χ²: n/a
Cases (case-drug + AE): n = 1359
Verdict: PASSES_ALL_GATES — PRR=40.64 (95% CI 38.53–42.86), n=1359 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: a3d1f4699fd1678bdd4b4c466ea6c4a2a0b6e43e