Table 3

 Summary of adverse events from week 22 through week 54 for patients in group 2

CategoryPatients without dose escalationPatients with dose escalation
Results are shown as No (%) unless stated otherwise.
Patients in study at week 22220109
Average duration of follow-up (weeks)31.931.7
Average exposure (weeks)31.030.6
Patients with one or more adverse event160 (72.7)77 (70.6)
Patients who discontinued study agent because of one or more adverse event7 (3.2)6 (5.5)
Patients with one or more serious adverse event19 (8.6)14 (12.8)
Patients with one or more infection80 (36.4)39 (35.8)
Patients with one or more serious infection5 (2.3)2 (1.8)