Table 3.
Treatment-related adverse events occurring in >10% of patients
| Caucasian patients n = 37 |
Korean patients n = 11 |
|||
|---|---|---|---|---|
| Any grade n (%) |
Grade 3/4 n (%) |
Any grade n (%) |
Grade 3/4 n (%) |
|
| Any treatment-related AE | 35 (94.6) | 29 (78.4) | 11 (100.0) | 11 (100.0) |
| Leukopenia | 21 (56.8) | 20 (54.1) | – | – |
| Neutropeniaa | 21 (56.8) | 20 (54.1) | 8 (72.7) | 8 (72.7) |
| Thrombocytopenia | 15 (40.5) | 5 (13.5) | 5 (45.5) | 1 (9.1) |
| Febrile neutropenia | 2 (5.4) | 2 (5.4) | 6 (54.5) | 6 (54.5) |
| Infusion-related reaction | 15 (40.5) | 3 (8.1) | 3 (27.3) | 0 |
| Chills | 13 (35.1) | 0 | 3 (27.3) | 0 |
| Lymphopenia | 10 (27.0) | 10 (27.0) | – | – |
| Decreased CD4 lymphocytes | 8 (21.6) | 8 (21.6) | – | – |
| Anemia | 6 (16.2) | 2 (5.4) | 1 (9.1) | 1 (9.1) |
| Fatigue | 6 (16.2) | 0 | 3 (27.3) | 0 |
| Pyrexia | 4 (10.8) | 0 | – | – |
| Elevated C-reactive protein | 4 (10.8) | 0 | – | – |
| Hypophosphatemia | 4 (10.8) | 2 (5.4) | – | – |
| Tachycardia | 4 (10.8) | 0 | – | – |
| Pneumonia | – | – | 2 (18.2) | 2 (18.2) |
| Headache | 1 (2.7) | 0 | 2 (18.2) | 0 |
| Decreased neutrophil counta | 2 (5.4) | 2 (5.4) | 3 (27.3) | 3 (27.3) |
AE adverse event, −, not listed, aDifferent preferred terms, no difference per definition