Table 2.
Distribution of CAR-T therapy-treated individual case safety reports (ICSRs) by cancer indication for each statistically significant adverse reaction signal
| 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 |
ALL Acute lymphocytic leukemia, DLBCL diffuse large B-cell lymphoma, MCL mantle cell lymphoma, VT/VF ventricular tachycardia/ventricular fibrillation. The asterisk (*) denotes the one patient who had both acute lymphocytic leukemia and diffuse large B-cell lymphoma for the adverse reaction of increased C-reactive protein.