Table 5 Overall Frequency of Adverse Events

 Any AE

111 (91.7)

113 (96.6)

 Any Grade ≥ 3 AE

23 (19.0)

18 (15.4)

 Any AE related to IMP

26 (21.5)

32 (27.4)

 Any serious AE

13 (10.7)

12 (10.3)

 Any IMP-related serious AE

0

0

 Any AE leading to withdrawal

2 (1.7)

4 (3.4)

 Any IMP-related AE leading to withdrawal

0

0

 Any AE with an outcome of death

2 (1.7)

0

 Any IMP-related AE with an outcome of death

0

0

 Any injection site reaction AE

2 (1.7)

2 (1.7)