Sotagliflozin → Abdominal discomfort — Audit-grade candidate (class scan)

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Ledger entry · candidate

Sotagliflozin → Abdominal discomfort — Audit-grade candidate (class scan)

Drug: sotagliflozin · AE: Abdominal discomfort

Discovered via class scan of SGLT2 inhibitors. PRR = 2.62, n = 11 cases.

Disproportionality

PRR: 2.619525264452701
Yates χ²: n/a
Cases (case-drug + AE): n = 11
Verdict: PASSES_ALL_GATES — PRR=2.62 (95% CI 1.46–4.70), n=11 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: eb520e9cd33f32e7b3e5dbe0ed1b1cd0c603f4e4