Table 3.
Case-seriousness rates calculated for cardiovascular and inflammatory adverse events associated with the CAR-T therapies of tisagenlecleucel and axicabtagene ciloleucel for diffuse large B-cell lymphoma patients
| Adverse Reaction | Total Cases | Number of Fatal Cases (% of Total) | Number of Life-Threatening Cases (% of Total) | Number of Caused/ Prolonged Hospitalization Cases (% of Total) |
|---|---|---|---|---|
| Tisagenlecleucel | ||||
| Atrial fibrillation | 8 | 4 (50.0%) | 1 (12.5%) | 2 (25.0%) |
| Tachycardia | 12 | 11 (91.7%) | 0 (0%) | 0 (0%) |
| Sinus tachycardia | 1 | 0 (0%) | 0 (0%) | 0 (0%) |
| Cardiac arrest | 1 | 1 (100%) | 0 (0%) | 0 (0%) |
| Pericardial effusion | 2 | 1 (50.0%) | 0 (0%) | 1 (50.0%) |
| Cardiac failure | 7 | 6 (85.7%) | 0 (0%) | 1 (14.3%) |
| Hypotension | 54 | 27 (50.0%) | 2 (3.7%) | 7 (13.0%) |
| Capillary leak syndrome | 1 | 1 (100%) | 0 (0%) | 0 (0%) |
| Axicabtagene Ciloleucel | ||||
| Atrial fibrillation | 3 | 1 (33.3%) | 0 (0%) | 1 (33.3%) |
| Atrial flutter | 1 | 0 (0%) | 1 (100%) | 0 (0%) |
| Tachycardia | 3 | 1 (33.3%) | 0 (0%) | 2 (66.7%) |
| Cardiac arrest | 1 | 1 (100%) | 0 (0%) | 0 (0%) |
| Hypotension | 18 | 1 (5.6%) | 4 (22.2%) | 9 (50.0%) |