Table 5.
Case-seriousness rates calculated for cardiovascular and inflammatory adverse events associated with tisagenlecleucel and blinatumomab for acute lymphocytic leukemia patients (aged 17 years or younger in both drug categories)
| 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 | ||||
| Tachycardia | 17 | 8 (47.1%) | 4 (23.5%) | 3 (17.6%) |
| Sinus tachycardia | 5 | 2 (40.0%) | 3 (60.0%) | 0 (0%) |
| Cardiac arrest | 3 | 3 (100%) | 0 (0%) | 0 (0%) |
| Pericardial effusion | 3 | 3 (100%) | 0 (0%) | 0 (0%) |
| Cardiac failure | 5 | 4 (80.0%) | 0 (0%) | 0 (0%) |
| Hypotension | 72 | 25 (34.7%) | 20 (27.8%) | 5 (6.9%) |
| Capillary leak syndrome | 1 | 1 (100%) | 0 (0%) | 0 (0%) |
| Blinatumomab | ||||
| Tachycardia | 2 | 1 (50.0%) | 1 (50.0%) | 0 (0%) |
| Sinus tachycardia | 2 | 2 (100%) | 0 (0%) | 0 (0%) |
| Pericardial effusion | 3 | 2 (66.7%) | 1 (33.3%) | 0 (0%) |
| Hypotension | 5 | 1 (20.0%) | 2 (40.0%) | 2 (40.0%) |