Table 4 Serious adverse events occurring in ≥0.5% of patients per agent

Total

338

189

21.2%

11.7

121

82

15.5%

11.2

12

6

3.8%

4.68

Cardiac disorders

20

18

2.0%

0.69

12

10

1.9%

1.11

0

0

0

0

Gastrointestinal disorders

12

10

1.1%

0.42

5

4

0.8%

0.46

2

1

0.6%

0.78

General disorders and administration site conditions

20

19

2.1%

0.69

7

7

1.3%

0.65

1

1

0.6%

0.39

Infections and infestations

77

58

6.5%

2.67

24

20

3.8%

2.23

3

2

1.3%

1.17

Injury, poisoning and procedural complications

30

21

2.4%

1.04

12

7

1.3%

1.11

1

1

0.6%

0.39

Metabolism and nutrition disorders

8

5

0.6%

0.28

1

1

0.2%

0.09

0

0

0

0

Musculoskeletal and connective tissue disorders

37

25

2.8%

1.28

12

10

1.9%

1.11

0

0

0

0

Neoplasms benign, malignant and unspecified

45

40

4.5%

1.56

16

14

2.6%

1.49

1

1

0.6%

0.39

Nervous system disorders

18

16

1.8%

0.62

10

9

1.7%

0.93

1

1

0.6%

0.39

Renal and urinary disorders

2

2

0.2%

0.07

4

3

0.6%

0.37

0

0

0

0

Respiratory, thoracic and mediastinal disorders

25

20

2.2%

0.87

3

3

0.6%

0.28

1

1

0.6%

0.39

Skin and subcutaneous tissue disorders

5

5

0.6%

0.17

2

2

0.4%

0.19

1

1

0.6%

0.39

Surgical and medical procedures

10

9

1.0%

0.35

1

1

0.2%

0.09

1

1

0.6%

0.39

Vascular disorders

9

8

0.9%

0.31

0

0

0

0

1

1

0.6%

0.39

Cardiac disorders

20

18

2.0%

0.69

12

10

1.9%

1.11

0

0

0

0