Table 2

AEs of any grade occurring in at least 20% 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)
Fatigue3 (100)2 (67)9 (60)3 (50)46 (52)55 (53)
Nausea01 (33)7 (47)3 (50)31 (35)38 (37)
Insomnia2 (67)2 (67)5 (33)4 (67)28 (31)33 (32)
Headache02 (67)7 (47)4 (67)25 (28)32 (31)
Diarrhea2 (67)09 (60)2 (33)23 (26)32 (31)
Upper respiratory tract infection1 (33)2 (67)11 (73)2 (33)20 (22)31 (30)
Anemia2 (67)2 (67)5 (33)2 (33)24 (27)29 (28)
Dyspnea1 (33)1 (33)4 (27)2 (33)24 (27)28 (27)
Cough005 (33)2 (33)24 (27)29 (28)
Pyrexia007 (47)3 (50)19 (21)26 (25)
Thrombocytopenia003 (20)1 (17)20 (22)23 (22)
Peripheral edema01 (33)4 (27)018 (20)22 (21)