Isatuximab → Infusion related reaction — Null result

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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.

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Reference: 3489aa05d95482e5eeaa96ebacae5c6cb057338d