Table 2 Distribution of CAR-T therapy-treated individual case safety reports (ICSRs) by cancer indication for each statistically significant adverse reaction signal
From: Cardiotoxic profiles of CAR-T therapy and bispecific T-cell engagers in hematological cancers
Number of Reports for Each Indication | ||||||
---|---|---|---|---|---|---|
Reaction Name | ALL | DLBCL | MCL | Other Lymphomas and Leukemias | Unspecified Lymphomas and Leukemias | Unknown Indication |
Inflammatory/Effusive Events | ||||||
C-Reactive Protein Increased | 26 | 30 | 1 | 1* | 7 | 5 |
Capillary Leak Syndrome | 7 | 5 | 0 | 0 | 0 | 2 |
Pericardial Effusion | 9 | 4 | 0 | 1 | 2 | 2 |
Arrhythmic Events | ||||||
Tachycardia | 49 | 93 | 6 | 4 | 11 | 11 |
Atrial Fibrillation | 0 | 31 | 4 | 0 | 4 | 6 |
Atrial Flutter | 0 | 5 | 2 | 1 | 0 | 0 |
VT/VF | 5 | 9 | 1 | 0 | 0 | 0 |
Cardiac Arrest | 7 | 19 | 0 | 1 | 1 | 3 |
Hemodynamic Events | ||||||
Hypotension | 176 | 176 | 7 | 19 | 48 | 43 |
Sinus Tachycardia | 8 | 5 | 0 | 3 | 2 | 0 |
Cardiomyopathy-Related Events | ||||||
Stress Cardiomyopathy | 0 | 5 | 0 | 0 | 1 | 0 |
Ejection Fraction Decreased | 2 | 6 | 0 | 1 | 2 | 0 |
Cardiogenic Shock | 0 | 3 | 0 | 1 | 0 | 1 |