Table 3.

Cox proportional hazard analysis of risk factors for severe (grade ≥3) CAR T-cell–associated organ-based toxicities

HR (95% CI)
CardiovascularMetabolicHematologicInfection with sourceNeurologicPulmonary
Age, ≥60 vs <60 y 1.39 (0.37-5.24) 1.43 (0.68-3.02) 0.73 (0.37-1.45) 0.78 (0.32-1.94) 2.88 (0.62-13.3) 1.75 (0.35-8.70) 
CAR T-cell product, tisagenlecleucel vs axicabtagene ciloleucel N/A* 0.62 (0.27-1.44) 0.46 (0.19-1.13) 0.96 (0.35-2.64) 0.23 (0.03-1.80) 0.89 (0.18-4.43) 
Prior therapy, ≥3 vs <3) 1.73 (0.36-8.21) 1.45 (0.65-3.24) 0.88 (0.43-1.82) 2.96 (1.02-9.78) 1.16 (0.31-4.38) N/A* 
History of SCT, yes vs no 0.66 (0.15-3.00) 1.12 (0.52-2.42) 1.38 (0.67-2.84) 1.11 (0.43-2.90) 0.61 (0.13-2.82) 1.74 (0.43-7.29) 
Baseline LDH, normal vs high 0.65 (0.19-2.24) 0.53 (0.26-1.07) 0.55 (0.28-1.08) 1.13 (0.42-2.41) 0.19 (0.04-0.89) 0.12 (0.01-0.99) 
Performance status, ≥2 vs 0-1 0.42 (0.05-3.32) 2.41 (1.09-5.35) 0.94 (0.38-2.30) 1.88 (0.53-6.71) 2.82 (0.80-10.0) 1.46 (0.28-7.54) 
Bridging therapy before CAR T cell, yes vs no 2.56 (0.54-12.0) 1.24 (0.61-2.50) 1.29 (0.62-2.68) 0.49 (0.20-1.17) 6.40 (0.82-50.1) 4.40 (0.54-35.8) 
Time from leukapheresis to CAR T-cell infusion, d 0.88 (0.79-0.99) 0.99 (0.96-1.02) 0.99 (0.96-1.02) 1.00 (0.97-1.04) 0.97 (0.91-1.03) 0.95 (0.87-1.03) 
CRS, yes vs no 2.64 (0.72-9.75) 2.25 (1.06-4.75) 1.71 (0.87-3.35) 1.49 (0.59-3.75) 22.48 (2.83-178.32) 8.04 (1.37-47.05) 
HR (95% CI)
CardiovascularMetabolicHematologicInfection with sourceNeurologicPulmonary
Age, ≥60 vs <60 y 1.39 (0.37-5.24) 1.43 (0.68-3.02) 0.73 (0.37-1.45) 0.78 (0.32-1.94) 2.88 (0.62-13.3) 1.75 (0.35-8.70) 
CAR T-cell product, tisagenlecleucel vs axicabtagene ciloleucel N/A* 0.62 (0.27-1.44) 0.46 (0.19-1.13) 0.96 (0.35-2.64) 0.23 (0.03-1.80) 0.89 (0.18-4.43) 
Prior therapy, ≥3 vs <3) 1.73 (0.36-8.21) 1.45 (0.65-3.24) 0.88 (0.43-1.82) 2.96 (1.02-9.78) 1.16 (0.31-4.38) N/A* 
History of SCT, yes vs no 0.66 (0.15-3.00) 1.12 (0.52-2.42) 1.38 (0.67-2.84) 1.11 (0.43-2.90) 0.61 (0.13-2.82) 1.74 (0.43-7.29) 
Baseline LDH, normal vs high 0.65 (0.19-2.24) 0.53 (0.26-1.07) 0.55 (0.28-1.08) 1.13 (0.42-2.41) 0.19 (0.04-0.89) 0.12 (0.01-0.99) 
Performance status, ≥2 vs 0-1 0.42 (0.05-3.32) 2.41 (1.09-5.35) 0.94 (0.38-2.30) 1.88 (0.53-6.71) 2.82 (0.80-10.0) 1.46 (0.28-7.54) 
Bridging therapy before CAR T cell, yes vs no 2.56 (0.54-12.0) 1.24 (0.61-2.50) 1.29 (0.62-2.68) 0.49 (0.20-1.17) 6.40 (0.82-50.1) 4.40 (0.54-35.8) 
Time from leukapheresis to CAR T-cell infusion, d 0.88 (0.79-0.99) 0.99 (0.96-1.02) 0.99 (0.96-1.02) 1.00 (0.97-1.04) 0.97 (0.91-1.03) 0.95 (0.87-1.03) 
CRS, yes vs no 2.64 (0.72-9.75) 2.25 (1.06-4.75) 1.71 (0.87-3.35) 1.49 (0.59-3.75) 22.48 (2.83-178.32) 8.04 (1.37-47.05) 

SCT, stem cell transplantation.

*

N/A, not applicable because no event occurred in either subgroup, so HR could not be calculated for that comparison.

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