Ertugliflozin → No adverse event — Audit-grade candidate (class scan)

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Ledger entry · candidate

Ertugliflozin → No adverse event — Audit-grade candidate (class scan)

Drug: ertugliflozin · AE: No adverse event

Discovered via class scan of SGLT2 inhibitors. PRR = 6.44, n = 69 cases.

Disproportionality

PRR: 6.439655006101955
Yates χ²: n/a
Cases (case-drug + AE): n = 69
Verdict: PASSES_ALL_GATES — PRR=6.44 (95% CI 5.12–8.10), n=69 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: a8e3e20d2f45cff89759f2f958f5aa0be614709b