Table 3 Summary of number and percentage of subjects with treatment-emergent adverse events

Any AE

50 (58%)

65 (76%)

31 (72%)

Any SAE

0 (0%)

5 (6%)

1 (2%)

Any AE Grade ≥3

6 (7%)

8 (9%)

3 (7%)

Any drug-related AE

20 (23%)

26 (31%)

10 (23%)

Any AE within 24 hr of dosing

7 (8%)

27 (32%)

6 (14%)

Any SAE within 24 hr of dosing

0 (0%)

0 (0%)

0 (0%)

Any drug-related AE within 24 hr of dosing

4 (5%)

12 (14%)

5 (12%)

Any infection AE

25 (29%)

32 (38%)

19 (44%)

Any infection SAE

0 (0%)

2 (2%)

0 (0%)

Any infection AE Grade 3 or higher

0 (0%)

1 (1%)

0 (0%)

Any AE leading to discontinuation of study drug

2 (2%)

6 (7%)

1 (2%)

Any death

0 (0%)

0 (0%)

0 (0%)