Table 3.
Adverse event | No. of patients by event grade |
Total patients, n (%) | |||
---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
Treatment-related in ≥ 25% of patients | |||||
Thrombocytopenia | 6 | 7 | 8 | 3 | 24 (83) |
Neutropenia (ANC/AGC) | 1 | 4 | 11 | 7 | 23 (79) |
Anemia | 2 | 10 | 5 | 0 | 17 (59) |
Leukopenia | 1 | 5 | 10 | 1 | 17 (59) |
Fatigue (asthenia, lethargy, malaise) | 7 | 3 | 3 | 0 | 13 (45) |
Diarrhea | 7 | 1 | 2 | 0 | 10 (35) |
Hypocalcemia | 6 | 2 | 1 | 0 | 9 (31) |
Hyperglycemia | 3 | 2 | 4 | 0 | 9 (31) |
Nausea | 5 | 2 | 1 | 0 | 8 (28) |
Additional grades 3 or 4 | |||||
Hypokalemia | 1 | 0 | 4 | 1 | 6 (21) |
Dehydration | 0 | 0 | 2 | 0 | 2 (6) |
Prolonged QTc interval | 0 | 0 | 1 | 0 | 1 (3) |
Arrhythmia, atrial fibrillation | 0 | 0 | 1 | 0 | 1 (3) |
Infection with normal (pneumonia) | 0 | 0 | 1 | 0 | 1 (3) |
Febrile neutropenia | 0 | 0 | 1 | 0 | 1 (3) |
Pain, joint | 0 | 0 | 1 | 0 | 1 (3) |
ANC indicates absolute neutrophil count; and AGC, absolute granulocyte count.