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Table 5 Summary of adverse events

From: A phase I study comparing the biosimilarity of the pharmacokinetics and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection with Avastin® in healthy Chinese male subjects

System organ class

Test group

(N = 44)

Reference group

(N = 44)

Total

(N = 88)

Preferred term

Cases (incidence %)

Frequency

Cases (incidence %)

Frequency

Cases (incidence %)

Frequency

Total

40 (90.91)

152

41 (93.18)

153

81 (92.05)

305

Various inspections

37 (84.09)

105

33 (75.00)

81

70 (79.55)

186

Elevated white blood cell count

25 (56.82)

29

19 (43.18)

19

44 (50.00)

48

Elevated neutrophil count

15 (34.09)

16

12 (27.27)

12

27 (30.68)

28

Positive occult blood

8 (18.18)

8

6 (13.64)

6

14 (15.91)

14

positive urine white blood cells

4 (9.09)

5

7 (15.91)

8

11 (12.50)

13

positive urine red blood cell positive

4 (9.09)

4

4 (9.09)

8

8 (9.09)

12

Elevated blood bilirubin

6 (13.64)

8

1 (2.27)

1

7 (7.95)

9

Metabolic and nutritional diseases

20 (45.45)

36

27 (61.36)

42

47 (53.41)

78

Hypertriglyceridemia

13 (29.55)

15

14 (31.82)

16

27 (30.68)

31

Hyperglycemia

11 (25.00)

12

9 (20.45)

9

20 (22.73)

21

Hypokalemia

2 (4.55)

2

7 (15.91)

12

9 (10.23)

14

hyperuricemia

6 (13.64)

6

2 (4.55)

2

8 (9.09)

8

Respiratory, thoracic and mediastinal diseases

2 (4.55)

3

8 (18.18)

9

10 (11.36)

12

Runny nose

2 (4.55)

3

3 (6.82)

3

5 (5.68)

6

Infectious and infectious diseases

2 (4.55)

2

5 (11.36)

5

7 (7.95)

7

Upper respiratory tract infection

2 (4.55)

2

4 (9.09)

4

6 (6.82)

6

Gastrointestinal diseases

0

0

6 (13.64)

8

6 (6.82)

8

Skin and subcutaneous diseases

2 (4.55)

2

2 (4.55)

4

4 (4.55)

6

Kidney and urinary diseases

2 (4.55)

2

1 (2.27)

1

3 (3.41)

3

Heart organ disease

2 (4.55)

2

1 (2.27)

1

3 (3.41)

3

Various neurological diseases

0

0

2 (4.55)

2

2 (2.27)

2