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Table 2 The signal strength of ADEs of Asenapine at the SOC level in FAERS database

From: Safety assessment of asenapine in the FAERS database: real adverse event analysis and discussion on neurological and psychiatric side effects

SOC

Case reports

ROR (95% CI)

PRR (95% CI)

chisq

IC (IC025)

EBGM (EBGM05)

Psychiatric disorders

2641

3.42 (3.28, 3.56)

2.99 (2.88, 3.11)

3714.63

1.58 (1.52)

2.99 (2.88)

Nervous system disorders

3305

2.94 (2.83, 3.05)

2.51 (2.41, 2.61)

3285.74

1.33 (1.27)

2.51 (2.43)

Gastrointestinal disorders

2049

1.63 (1.55, 1.7)

1.54 (1.48, 1.6)

425.19

0.62 (0.56)

1.54 (1.48)

Reproductive system and breast disorders

125

0.97 (0.81, 1.15)

0.97 (0.81, 1.16)

0.14

-0.05 (-0.3)

0.97 (0.83)

Immune system disorders

172

0.96 (0.83, 1.12)

0.96 (0.82, 1.12)

0.25

-0.06 (-0.27)

0.96 (0.85)

Investigations

867

0.95 (0.89, 1.02)

0.96 (0.91, 1.02)

1.93

-0.07 (-0.16)

0.96 (0.9)

Metabolism and nutrition disorders

283

0.87 (0.77, 0.98)

0.87 (0.77, 0.98)

5.67

-0.2 (-0.37)

0.87 (0.79)

Injury, poisoning and procedural complications

1190

0.79 (0.74, 0.84)

0.81 (0.76, 0.86)

62.18

-0.31 (-0.4)

0.81 (0.77)

Respiratory, thoracic and mediastinal disorders

539

0.72 (0.66, 0.79)

0.73 (0.67, 0.79)

54.74

-0.45 (-0.57)

0.73 (0.68)

Vascular disorders

203

0.61 (0.53, 0.7)

0.61 (0.53, 0.7)

50.84

-0.71 (-0.91)

0.61 (0.55)

Musculoskeletal and connective tissue disorders

480

0.58 (0.53, 0.63)

0.59 (0.55, 0.64)

144.81

-0.76 (-0.89)

0.59 (0.55)

General disorders and administration site conditions

1757

0.58 (0.55, 0.6)

0.62 (0.6, 0.64)

486.75

-0.68 (-0.75)

0.63 (0.6)

Eye disorders

182

0.57 (0.5, 0.67)

0.58 (0.51, 0.67)

56.53

-0.79 (-1)

0.58 (0.51)

Ear and labyrinth disorders

38

0.57 (0.41, 0.78)

0.57 (0.42, 0.78)

12.3

-0.81 (-1.26)

0.57 (0.44)

Cardiac disorders

222

0.57 (0.5, 0.65)

0.57 (0.5, 0.65)

71.95

-0.8 (-0.99)

0.57 (0.51)

Skin and subcutaneous tissue disorders

488

0.55 (0.5, 0.6)

0.57 (0.53, 0.62)

172.38

-0.82 (-0.95)

0.57 (0.52)

Renal and urinary disorders

124

0.44 (0.36, 0.52)

0.44 (0.37, 0.52)

90.03

-1.18 (-1.44)

0.44 (0.38)

Endocrine disorders

14

0.37 (0.22, 0.62)

0.37 (0.22, 0.63)

15.33

-1.45 (-2.18)

0.37 (0.24)

Hepatobiliary disorders

44

0.33 (0.24, 0.44)

0.33 (0.25, 0.44)

59.92

-1.59 (-2.02)

0.33 (0.26)

Congenital, familial and genetic disorders

13

0.28 (0.16, 0.48)

0.28 (0.16, 0.48)

24.53

-1.85 (-2.61)

0.28 (0.18)

Blood and lymphatic system disorders

52

0.2 (0.15, 0.26)

0.2 (0.15, 0.26)

167.02

-2.31 (-2.7)

0.2 (0.16)

Infections and infestations

135

0.16 (0.13, 0.19)

0.17 (0.14, 0.2)

595.48

-2.59 (-2.83)

0.17 (0.14)

Pregnancy, puerperium and perinatal conditions

8

0.12 (0.06, 0.24)

0.12 (0.06, 0.24)

52.81

-3.08 (-4.02)

0.12 (0.07)

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

21

0.05 (0.03, 0.07)

0.05 (0.03, 0.08)

417.28

-4.41 (-5.01)

0.05 (0.03)