Table 4 AEs within 10 weeks since treatment and within 24-week treatment

Any AE, n (%)

154 (91.7)

162 (94.7)

81 (95.3)

332 (97.9)

85 (100.0)

AEs leading to dose discontinuation, n (%)

2 (1.2)

2 (1.2)

4 (4.7)

11 (3.2)

7 (8.2)

AEs leading to dose interruption or reduction, n (%)

6 (3.6)

30 (17.5)

1 (1.2)

47 (13.9)

7 (8.2)

AESI, n (%)

0

0

0

2 (0.6)

1 (1.2)

Most common AEs (≥ 10% of patients in either treatment group), n (%)

 Upper respiratory tract infection

44 (26.2)

45 (26.3)

29 (34.1)

143 (42.2)

39 (45.9)

 Urinary tract infection

20 (11.9)

28 (16.4)

14 (16.5)

58 (17.1)

18 (21.2)

 Platelet count increased

4 (2.4)

24 (14.0)

2 (2.4)

39 (11.5)

7 (8.2)

 Blood urine present

24 (14.3)

21 (12.3)

11 (12.9)

49 (14.5)

13 (15.3)

 Blood lactate dehydrogenase increased

12 (7.1)

21 (12.3)

6 (7.1)

40 (11.8)

9 (10.6)

 Immune thrombocytopenic purpura

23 (13.7)

21 (12.3)

25 (29.4)

58 (17.1)

28 (32.9)

 Red blood cells urine positive

24 (14.3)

14 (8.2)

13 (15.3)

47 (13.9)

17 (20.0)

 Alanine aminotransferase increased

11 (6.5)

13 (7.6)

8 (9.4)

32 (9.4)

16 (18.8)

 Diarrhea

17 (10.1)

13 (7.6)

1 (1.2)

39 (11.5)

3 (3.5)

 Gingival bleeding

11 (6.5)

13 (7.6)

9 (10.6)

32 (9.4)

11 (12.9)

 Headache

13 (7.7)

12 (7.0)

8 (9.4)

33 (9.7)

9 (10.6)

 Hypokalemia

7 (4.2)

10 (5.8)

14 (16.5)

24 (7.1)

14 (16.5)

 Protein urine present

11 (6.5)

7 (4.1)

8 (9.4)

19 (5.6)

9 (10.6)

 Hepatic function abnormal

3 (1.8)

4 (2.3)

6 (7.1)

16 (4.7)

10 (11.8)

Any SAE, n (%)

16 (9.5)

15 (8.8)

17 (20.0)

49 (14.5)

21 (24.7)

Most common SAEs (≥ 2 patients in either treatment group), n (%)

 Thrombocytopenia*

15 (8.9)

9 (5.3)

16 (18.8)

34 (10.0)

18 (21.2)

 Gastrointestinal hemorrhage

3 (1.8)

0

0

3 (0.9)

0

 Cerebral hemorrhage

2 (1.2)

0

0

2 (0.6)

0

Death, n (%)

1 (0.6)

1 (0.6)

1 (1.2)

2 (0.6)

1 (1.2)