Table 5 Most common AE in the study by Osmers et al. (2005) [41] by system organ class (MedDRA)

Infections and infestations

13

19

32 (10.5)

Musculoskeletal and connective tissue disorders

15

10

25 (8.2)

Gastrointestinal disorders

8

7

15 (4.9)

Investigations

6

5

11 (0.4)

Nervous system disorders

4

5

9 (3.0)

Reproductive system and breast disorders

4

4

8 (2.6)

Psychiatric disorders

2

5

7 (2.3)

Skin and subcutaneous disorders

3

3

6 (2.0)

Blood and lymphatic disorders

1

1

2 (0.7)

Cardiac disorders

2

2 (0.7)

General disorders and administration site conditions

1

1

2 (0.7)

Vascular disorders

1

1

2 (0.7)

Injury poisoning and procedural complications

2

2 (0.7)

Metabolism and nutrition disorders

2

2 (0.7)

Ear and labyrinth disorders

1

1 (0.3)

Renal and urinary disorders

1

1 (0.3)

Respiratory, thoracic and mediastinal disorders

1

1 (0.3)