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Causality: well established
Causality assessment · Causality: well established
Ciltacabtagene Autoleucel 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.
Ciltacabtagene Autoleucel ↔ Cytokine Release Syndrome
n=813 co-reports · PRR 159.1 · ROR 184.5
Ciltacabtagene autoleucel (Carvykti) is a BCMA-directed CAR T-cell therapy. CRS is the expected on-target pharmacological effect; the label carries a boxed warning. 219 co-reports (PRR 61.1) in a smaller treated population reflect universal occurrence.
Boxed warning: Carvykti label (CRS). Registration trial: NCT04457624.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 61.1 with 219 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 Ciltacabtagene captured cytokine release syndrome as a tracked adverse event in a usable structure. CRS is tracked as primary AE in CAR T registration trials.