Table 2.
Drug-Related Adverse Events ≥ 10% (all grades) or Grade ≥ 3 in Two or More Patients
| Type of Adverse Event | All-Grade Adverse Events | Grade ≥ 3 Adverse Events* |
|---|---|---|
| Any drug-related adverse events | 32 (86) | 24 (65) |
| Anemia | 22 (59) | 11 (30) |
| Thrombocytopenia | 17 (46) | 9 (24) |
| Fatigue | 17 (46) | 1 (3) |
| Neutropenia | 16 (43) | 12 (32) |
| Leukopenia | 15 (41) | 7 (19) |
| Lymphopenia | 12 (32) | 8 (22) |
| Alopecia | 9 (24) | — |
| Mucositis | 8 (22) | 4 (11) |
| Alkaline phosphatase increased | 7 (19) | 2 (5) |
| Anorexia | 7 (19) | 1 (3) |
| Fever | 7 (19) | 1 (3) |
| Diarrhea | 6 (16) | 1 (3) |
| Febrile neutropenia | 5 (14) | 5 (14) |
| Bilirubin increased | 5 (14) | 1 (3) |
| AST increased | 5 (14) | — |
| Hyponatremia | 5 (14) | — |
| Rash | 4 (11) | 2 (5) |
| Creatinine increased | 4 (11) | — |
| Weight loss | 4 (11) | — |
| Pain | — | 2 (5) |
| CD4 lymphocytes decreased | — | 2 (5) |
NOTE: Data are given as number (percentage) of 37.
*
Grade ≥ 3 adverse events occurring in one patient each (3%) and not mentioned above were as follows: abdominal pain, back pain, hypercalcemia, hyperglycemia, hypotension, leukocytosis, pneumonia, sepsis, skin infection, gastrointestinal hemorrhage, and toxic epidermal necrolysis.