Table 2 Disproportionality analysis at SOC level

Injury, poisoning and procedural complications

253

1.33 (1.16—1.53)

1.28 (17.98)

1.28 (1.12)

0.36 (-1.31)

General disorders and administration site conditions

210

0.68 (0.59—0.79)

0.73 (26.15)

0.73 (0.63)

-0.46 (-2.13)

Skin and subcutaneous tissue disorders

195

2.18 ( 1.87—2.53)

2.04 (110.14)

2.04 (1.76)

1.03 (-0.64)

Respiratory, thoracic and mediastinal disorders

178

2.56 (2.20—3.00)

2.40 (151.54)

2.40 (2.05)

1.26 (-0.41)

Infections and infestations

156

1.77 (1.50—2.09)

1.70 (47.55)

1.70 (1.44)

0.76 (-0.90)

Gastrointestinal disorders

108

0.82 (0.67—1.00)

0.83 (4.00)

0.83 (0.68)

-0.27 (-1.93)

Investigations

91

0.94 (0.76—1.17)

0.95 (0.28)

0.95 (0.77)

-0.08 (-1.75)

Vascular disorders

77

2.58 (2.05—3.24)

2.50 (70.82)

2.50 (1.99)

1.32 (-0.34)

Blood and lymphatic system disorders

70

2.59 (2.04—3.29)

2.52 (65.34)

2.52 (1.98)

1.33 (-0.33)

Nervous system disorders

58

0.46 (0.35—0.60)

0.48 (35.22)

0.48 (0.37)

-1.06 (-2.73)

Metabolism and nutrition disorders

46

1.46 (1.09—1.96)

1.45 (6.53)

1.45 (1.08)

0.54 (-1.13)

Cardiac disorders

36

1.11 (0.80—1.55)

1.11 (0.39)

1.11 (0.80)

0.15 (-1.52)

Neoplasms benign, malignant and unspecified

32

0.50 (0.35—0.71)

0.51 (15.47)

0.51 (0.36)

-0.97 (-2.63)

Musculoskeletal and connective tissue disorders

31

0.36 (0.25—0.51)

0.37 (35.39)

0.37 (0.26)

-1.44 (-3.11)

Eye disorders

25

0.80 (0.54—1.19)

0.80 (1.25)

0.80 (0.54)

-0.32 (-1.99)

Immune disorders

24

1.20 (0.80—1.80)

1.20 (0.80)

1.20 (0.80)

0.26 (-1.41)

Hepatobiliary disorders

15

1.12 (0.67—1.86)

1.12 (0.19)

1.12 (0.67)

0.16 (-1.51)

Renal and urinary disorders

11

0.32 (0.18—0.58)

0.33 (15.71)

0.33 (0.18)

-1.62 (-3.29)

Psychiatric disorders

10

0.11 (0.06—0.20)

0.11 (74.00)

0.11 (0.06)

-3.15 (-4.82)

Surgical and medical procedures

7

0.30 (0.14—0.63)

0.30 (11.53)

0.30 (0.14)

-1.73 (-3.40)

Breast problems

5

0.47 (0.19—1.13)

0.47 (3.00)

0.47 (0.20)

-1.09 (-2.76)

Ear and labyrinth disorders

4

0.59 (0.22—1.57)

0.59 (1.14)

0.59 (0.22)

-0.76 (-2.43)

Product issues

2

0.07 (0.02—0.26)

0.07 (26.31)

0.07 (0.02)

-3.89 (-5.56)