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

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Ledger entry · candidate

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

Drug: ertugliflozin · AE: Diabetic ketoacidosis

Discovered via class scan of SGLT2 inhibitors. PRR = 34.94, n = 59 cases.

Disproportionality

PRR: 34.94447792512535
Yates χ²: n/a
Cases (case-drug + AE): n = 59
Verdict: PASSES_ALL_GATES — PRR=34.94 (95% CI 27.23–44.84), n=59 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: cc77930ac5378ad5f85ca31b675032d04fa8d15c