Table 3

Grade 3 (or higher) AEs occurring in at least 3% of all patients

AE, n (%)Phase 1Phase 2Phase 1-2
45 mg/m2 (n = 3)56 mg/m2 (n = 3)70 mg/m2 (n = 15)88 mg/m2 (n = 6)70 mg/m2 (n = 89)70 mg/m2 (n = 104)
Fatigue001 (7)1 (17)10 (11)11 (11)
Pneumonia001 (7)05 (6)6 (6)
Acute kidney injury00006 (7)6 (6)
Hypertension00007 (8)7 (7)
Thrombocytopenia002 (13)04 (4)6 (6)
Anemia00006 (7)6 (6)
Asthenia00005 (6)5 (5)
Back pain002 (13)03 (3)5 (5)
COPD002 (13)03 (3)5 (5)
Blood creatinine increased1 (33)0003 (3)3 (3)
Congestive cardiac failure0001 (17)2 (2)2 (2)
Diarrhea00004 (4)4 (4)
Headache001 (7)1 (17)2 (2)3 (3)
Hypokalemia1 (33)0003 (3)3 (3)
Hypoxia00004 (4)4 (4)
Neutropenia001 (7)03 (3)4 (4)
Pain in extremity001 (7)02 (2)3 (3)
Upper respiratory tract infection01 (33)1 (7)1 (17)01 (1)
Sepsis00003 (3)3 (3)
Dyspnea001 (7)04 (4)5 (5)
Hypophosphatemia00003 (3)3 (3)
Hyperglycemia0001 (17)2 (2)2 (2)
Spinal cord compression001 (7)02 (2)3 (3)
  • COPD, chronic obstructive pulmonary disease.