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Causality: well established
Causality assessment · Causality: well established
Lisocabtagene Maraleucel and Cytokine Release Syndrome: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Lisocabtagene Maraleucel ↔ Cytokine Release Syndrome
n=352 co-reports · PRR 466.6 · ROR 798.3
Lisocabtagene maraleucel (Breyanzi) is a CD19-directed CAR T-cell therapy. CRS is the expected on-target effect; the label carries a boxed warning. 236 co-reports (PRR 156.7) reflect universal occurrence.
Boxed warning: Breyanzi label (CRS). Registration trial (TRANSCEND, NCT02631044).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 156.7 with 236 co-reports |
| Consistency | met | Reproduced across CAR T class |
| Specificity | partial | Specific to CAR T |
| Biological gradient | met | Correlates with tumour burden |
| Plausibility | met | Known cytokine mechanism |
| Coherence | met | Coherent with biology |
| Experiment | met | Trials confirm |
| Analogy | met | Class-wide pattern |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Lisocabtagene captured cytokine release syndrome as a tracked adverse event in a usable structure. CRS is tracked as primary AE in CAR T registration trials (TRANSCEND).