Table 1 Overall summary of AEs, and treatment-related AEs occurring in >10% of patients
Any grade n (%) | Grade 3 or 4 n (%) | |
|---|---|---|
Any AE | 37 (100) | 31 (83.8) |
Treatment-related AE | 35 (94.6) | 27 (73.0) |
Any SAE | 18 (48.6) | 13 (35.1) |
Treatment-related SAE | 12 (32.4) | 8 (21.6) |
AE leading to treatment discontinuation | 10 (27.0) | 7 (18.9) |
Most common treatment-related AEs | ||
Infusion-related reaction | 26 (70.3) | 3 (8.1) |
Chills | 22 (59.5) | 0 (0.0) |
Pyrexia | 18 (48.6) | 1 (2.7) |
Neutropenia | 17 (45.9) | 16 (43.2) |
Thrombocytopenia | 12 (32.4) | 9 (24.3) |
Anemia | 10 (27.0) | 6 (16.2) |
Dyspnea | 8 (21.6) | 2 (5.4) |
Nausea | 8 (21.6) | 0 (0.0) |
Leukopenia | 7 (18.9) | 6 (16.2) |
Hypertension | 5 (13.5) | 2 (5.4) |
Vomiting | 5 (13.5) | 0 (0.0) |
Aspartate aminotransferase increased | 5 (13.5) | 0 (0.0) |
C-reactive protein increased | 5 (13.5) | 0 (0.0) |
Alanine aminotransferase increased | 4 (10.8) | 1 (2.7) |
Hypotension | 4 (10.8) | 1 (2.7) |
Asthenia | 4 (10.8) | 0 (0.0) |
Hyperhidrosis | 4 (10.8) | 0 (0.0) |
