Ledger entry · null-result
Isatuximab → Infusion related reaction — Null result
Drug: isatuximab · AE: Infusion related reaction
Caliper validation of the submitted claim (drug=isatuximab, AE=Infusion related reaction). COEXPOSURE_CONFOUNDED — ? at 0% co-exposure; signal not attributable to isatuximab alone
Disproportionality
- PRR: 14.854375964826183
(95% CI 13.16–16.77)
- Yates χ2: 3201.4328599357304
- Cases (case-drug + AE): n = 249
- Verdict:
COEXPOSURE_CONFOUNDED — ? at 0% co-exposure; signal not attributable to isatuximab alone
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.