Table 2.
Adverse events occurring at incidence ≥20 % or grade 3/4 adverse events occurring at incidence ≥5 % regardless of relation to study treatment
| Adverse event, n (%) | 35 mg/m2 (n = 24) | All patients (N = 27) | ||
|---|---|---|---|---|
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Hematologic | ||||
| Neutropenia | 19 (79.2) | 17 (70.8) | 21 (77.8) | 19 (70.4) |
| Anemia | 11 (45.8) | 6 (25.0) | 11 (40.7) | 6 (22.2) |
| Thrombocytopenia | 6 (25.0) | 1 (4.2) | 6 (22.2) | 1 (3.7) |
| Leukopenia | 5 (20.8) | 4 (16.7) | 6 (22.2) | 5 (18.5) |
| Lymphopenia | 3 (12.5) | 2 (8.3) | 3 (11.1) | 2 (7.4) |
| Febrile neutropenia | 2 (8.3) | 2 (8.3) | 2 (7.4) | 2 (7.4) |
| Non-hematologic | ||||
| Fatigue | 15 (62.5) | 0 | 16 (59.3) | 0 |
| Nausea | 11 (45.8) | 1 (4.2) | 13 (48.1) | 1 (3.7) |
| Vomiting | 11 (45.8) | 1 (4.2) | 12 (44.4) | 1 (3.7) |
| Diarrhea | 10 (41.7) | 1 (4.2) | 10 (37.0) | 1 (3.7) |
| Decreased appetite | 10 (41.7) | 0 | 10 (37.0) | 0 |
| Constipation | 6 (25.0) | 0 | 6 (22.2) | 0 |
| Blood ALP increased | 4 (16.7) | 2 (8.3) | 4 (14.8) | 2 (7.4) |
| Hyponatremia | 4 (16.7) | 2 (8.3) | 4 (14.8) | 2 (7.4) |
ALP alkaline phosphatase