Sotagliflozin → Diarrhoea — Audit-grade candidate (class scan)

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Ledger entry · candidate

Sotagliflozin → Diarrhoea — Audit-grade candidate (class scan)

Drug: sotagliflozin · AE: Diarrhoea

Discovered via class scan of SGLT2 inhibitors. PRR = 2.87, n = 47 cases.

Disproportionality

PRR: 2.87229021109583
Yates χ²: n/a
Cases (case-drug + AE): n = 47
Verdict: PASSES_ALL_GATES — PRR=2.87 (95% CI 2.19–3.77), n=47 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: d1f74fe219a877403c4109629433f4f480cbca3d