Safety and tolerability
diarrhea, phlebitis, sinus tachycardia, vomiting, bacterial pneumonia, thrombocytosis, SAD
THROMBOCYTOSIS, BACTERIAL PNEUMONIA, SINUS TACHYCARDIA, PHLEBITIS
In Study 1 SAD and MAD phases, 30 (56.6%) and 57 (73.1%) patients in the lumicitabine groups had at least one AE, as compared to 4 (23.5%) and 20 (60.6%) patients in the corresponding placebo groups.In the SAD phase, the most frequently reported AEs included thrombocytosis (n = 7), followed by vomiting (n = 5) and diarrhea (n = 4). Overall, 8 (15.1%) patients in the lumicitabine group experienced at least 1 AE considered as possibly related to the study drug by the investigator. In the lumicitabine groups, 2 patients experienced serious treatment-emergent AEs of sinus tachycardia and phlebitis; one patient in the placebo group experienced Grade 3 bacterial pneumonia (