Safety
cerebellar haemorrhage, bleeding, purpura, petechiae, epistaxis
BLEEDING, ADVERSE EVENT, EVENT, HAEMORRHAGE SUBCUTANEOUS, PURPURA, PETECHIAE, EPISTAXIS, EVENTS
During part A, the incidence of AEs was 41.4% (12/29) with TAS 5315 4 mg, 44.8% (13/29) with TAS5315 2 mg and 57.6% (19/33) with placebo (Adverse events (AEs) in all patients who received at least one dose of the study drug (TAS5315 or placebo) in part ADuring the 36 weeks of parts A and B, the incidence of AEs was 66.7% (28/42) in the TAS5315 4 mg combined group and 64.3% (27/42) in the TAS5315 2 mg combined group (In both parts A and B, 13 AEs of special interest occurred in nine patients during TAS5315 administration. These events were haemorrhage subcutaneous (six events; five with TAS5315 4 mg and one with TAS5315 2 mg), petechiae (three events; two with TAS5315 4 mg and one with TAS5315 2 mg), purpura (two events; one in each TAS5315 dose group), cerebellar haemorrhage (one event with TAS5315 4 mg) and epistaxis (one event with TAS5315 2 mg).Over 36 weeks, nine patients experienced bleeding events, of whom four and two patients recovered with drug continuation and interruption, respectively. Three patients recovered with discontinuation of TAS5315. Except for a single severe cerebellar haemorrhage event, all other AEs of special interest were of mild severity.Overall, there was no significant difference in AE incidence between the TAS5315 combined group and the placebo group in part A (12 weeks) of this study, although the likelihood of TAS5315 causing bleeding-related AEs cannot be denied. No dose-dependent increases in AEs were observed with TAS5315. There were no clinically significant changes or abnormalities in laboratory data, vital signs or 12-lead electrocardiography.