Thirteen SAEs in patients (white blood cell count decreased, platelet count decreased, 2 cases of neutrophil count decreased, febrile neutropenia, 5 cases of thrombocytopenia, 2 cases of neutropenia, and diarrhea) were considered by the investigator to be probably related to study treatment; 4 SAEs (2 cases of febrile neutropenia, urinary tract infection, and anemia) were considered possibly related; 1 SAE (lung infection) was considered remotely related; and the other 6 SAEs (infection, sciatica, non-cardiac chest pain, dyspnea, wrist fracture, and neutropenia) were considered unrelated. Three patients died due to disease progression.