Sotagliflozin → Therapy interrupted — Audit-grade candidate (class scan)

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Ledger entry · candidate

Sotagliflozin → Therapy interrupted — Audit-grade candidate (class scan)

Drug: sotagliflozin · AE: Therapy interrupted

Discovered via class scan of SGLT2 inhibitors. PRR = 19.71, n = 33 cases.

Disproportionality

PRR: 19.709594082022885
Yates χ²: n/a
Cases (case-drug + AE): n = 33
Verdict: PASSES_ALL_GATES — PRR=19.71 (95% CI 14.17–27.42), n=33 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: fe09ed8e3e747336a0a5b33917dcdd5ef44f9965