Table 4 Distribution of AE signals in each SOC

Nervous system disorders

42(25.6)

16(15.8)

22(24.2)

6(28.6)

General disorders and administration site conditions

15(9.1)

8(7.9)

3(3.3)

2(9.5)

Vascular disorders

14(8.5)

3(3.0)

2(2.2)

0(0)

Eye disorders

11(6.7)

4(4.0)

1(1.1)

0(0)

Musculoskeletal and connective tissue disorders

11(6.7)

9(8.9)

4(4.4)

1(4.8)

Respiratory, thoracic and mediastinal disorders

9(5.5)

14(13.9)

10(11.0)

2(9.5)

Investigations

8(4.9)

7(6.9)

2(2.2)

1(4.8)

Gastrointestinal disorders

7(4.3)

7(6.9)

5(5.5)

4(19.0)

Psychiatric disorders

7(4.3)

5(5.0)

8(8.8)

2(9.5)

Cardiac disorders

6(3.7)

6(5.9)

10(11.0)

0(0)

Skin and subcutaneous tissue disorders

6(3.7)

2(2.0)

3(3.3)

0(0)

Pregnancy, puerperium and perinatal conditions

5(3.0)

0(0)

1(1.1)

0(0)

Infections and infestations

4(2.4)

9(8.9)

3(3.3)

0(0)

Reproductive system and breast disorders

4(2.4)

0(0)

1(1.1)

0(0)

Endocrine disorders

3(1.8)

1(1.0)

0(0)

0(0)

Renal and urinary disorders

3(1.8)

1(1.0)

1(1.1)

2(9.5)

Blood and lymphatic system disorders

2(1.2)

0(0)

0(0)

0(0)

Ear and labyrinth disorders

2(1.2)

5(5.0)

4(4.4)

0(0)

Social circumstances

2(1.2)

0(0)

1(1.1)

0(0)

Congenital, familial and genetic disorders

1(0.6)

1(1.0)

1(1.1)

0(0)

Immune system disorders

1(0.6)

2(2.0)

5(5.5)

0(0)

Metabolism and nutrition disorders

1(0.6)

1(1.0)

1(1.1)

1(4.8)

Hepatobiliary disorders

0(0)

0(0)

2(2.2)

0(0)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

0(0)

0(0)

1(1.1)

0(0)