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

← All findings ⬇ Download signed audit packet

Ledger entry · candidate

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

Drug: sotagliflozin · AE: Hospitalisation

Discovered via class scan of SGLT2 inhibitors. PRR = 3.41, n = 13 cases.

Disproportionality

PRR: 3.414143116084193
Yates χ²: n/a
Cases (case-drug + AE): n = 13
Verdict: PASSES_ALL_GATES — PRR=3.41 (95% CI 2.00–5.84), n=13 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.

Independent Verification & Validation

Every finding includes an in-engine adversary review at no cost. For findings you plan to cite in a regulatory submission, scientific publication, or board-grade decision, we offer an additional layer of independent, audit-grade verification — reviewed by an externally-trained system that has never seen your data, your training corpus, or our hardware, and cryptographically signed.

Reference: c94296330e1ef7d48956b043ba2516fb5f2c4705