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

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Ledger entry · candidate

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

Drug: sotagliflozin · AE: Dizziness

Discovered via class scan of SGLT2 inhibitors. PRR = 4.08, n = 52 cases.

Disproportionality

PRR: 4.0785038398463005
Yates χ²: n/a
Cases (case-drug + AE): n = 52
Verdict: PASSES_ALL_GATES — PRR=4.08 (95% CI 3.15–5.28), n=52 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: 9ae2c6e40aa51a6e23088310dcc93a9e4c53db2b