Table 3.
Safety analysis.
| Patients with cytokine release syndrome (CRS) | N (%) | Male (%) | Famale (%) |
|---|---|---|---|
| Total | 12 (75.0) | 7 (70) | 5 (83.3) |
| Grade 1 | 9 (56.3) | 5 (50) | 4 (66.7) |
| Grade 2 | 1 (6.3) | 0 (0) | 1 (16.7) |
| Grade 3 | 2 (12.5) | 2 (20) | 0 (0) |
| Grade 4 | 0 (0) | 0 (0) | 0 (0) |
| Time to cytokine release syndrome onset, days | 0 (0-4) | 0 (0-4) | 1 (0-1) |
| Time to cytokine release syndrome resolution, days | 10 (6-41) | 11 (6-41) | 10 (7-17) |
| Duration of CRS (day,range) | 8.5 (6-41) | 8 (6-41) | 10 (6-16) |
| Patients with neurological events | 1 (6.3) | 1 (10) | 0 (0) |
| Time to CRS onset, days | 3 | 3 | |
| Time to CRS resolution, days | 9 | 9 | |
| Medication for cytokine release syndrome | |||
| Corticosteroids | 6 (37.5) | 4 (40) | 2 (33.3) |
| Monoclonal antibody | 3 (18.8) | 2 (20) | 1 (16.6) |
| Infections | |||
| Pulmonary infections | 3 (18.8) | 3 (30) | 0 (0) |
| Intestinal infection | 5 (31.3) | 2 (20) | 3 (50) |
| COVID-19 infection | 1 (6.3) | 1 (10) | 0 (0) |
| Perianal infection | 1 (6.3) | 1 (10) | 0 (0) |
| Other adverse events of special interest | |||
| Agranulocytosis>15days | 7 (43.8) | 4 (40) | 3 (50) |
| Tumor lysis syndrome | 0 (0) | 0 (0) | 0 (0) |
| Second primary malignancy | 0 (0) | 0 (0) | 0 (0) |
| Hypogammaglobulinemia | 10 (62.5) | 6 (60) | 4 (66.7) |