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Table 3 The signal strength of AEs related to deutetrabenazine at the SOC level in the FAERS database was detected by four algorithms

From: Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database

System organ class (SOC)

Case reports

ROR (95% CI)

PRR (95% CI)

EBGM

(EBGM05)

IC (IC025)

General Disorders And Administration Site Conditions*

2167

1.2 (1.14–1.26)

1.16 (56.31)

1.16 (1.11)

0.21 (-1.46)

Nervous System Disorders*

2081

2.97 (2.83–3.12)

2.59 (2187.04)

2.58 (2.48)

1.37 (-0.3)

Psychiatric Disorders*

1937

3.98 (3.79–4.18)

3.44 (3535.18)

3.44 (3.3)

1.78 (0.11)

Injury, Poisoning And Procedural Complications

1150

0.91 (0.86–0.97)

0.92 (8.64)

0.92 (0.88)

-0.12 (-1.78)

Gastrointestinal Disorders

673

0.77 (0.71–0.83)

0.78 (43.82)

0.78 (0.73)

-0.35 (-2.02)

Musculoskeletal And Connective Tissue Disorders

342

0.62 (0.56–0.69)

0.63 (77.99)

0.63 (0.58)

-0.67 (-2.33)

Investigations

309

0.49 (0.43–0.54)

0.5 (162.75)

0.5 (0.46)

-1 (-2.66)

Surgical And Medical Procedures*

307

2.04 (1.82–2.29)

2.01 (158.35)

2.01 (1.83)

1.01 (-0.66)

Respiratory, Thoracic And Mediastinal Disorders

301

0.61 (0.54–0.68)

0.62 (74.08)

0.62 (0.56)

-0.69 (-2.36)

Social Circumstances*

220

4.5 (3.94–5.15)

4.43 (586.21)

4.43 (3.96)

2.15 (0.48)

Infections And Infestations

185

0.3 (0.26–0.35)

0.32 (290.38)

0.32 (0.28)

-1.66 (-3.33)

Skin And Subcutaneous Tissue Disorders

176

0.27 (0.23–0.31)

0.28 (340.69)

0.28 (0.25)

-1.82 (-3.49)

Metabolism And Nutrition Disorders

138

0.65 (0.55–0.77)

0.66 (25.25)

0.66 (0.57)

-0.61 (-2.27)

Cardiac Disorders

133

0.61 (0.52–0.73)

0.62 (32.48)

0.62 (0.53)

-0.7 (-2.36)

Eye Disorders

122

0.58 (0.49–0.7)

0.59 (35.54)

0.59 (0.51)

-0.76 (-2.43)

Renal And Urinary Disorders

71

0.33 (0.26–0.41)

0.33 (97.69)

0.33 (0.27)

-1.59 (-3.26)

Vascular Disorders

68

0.34 (0.26–0.43)

0.34 (88.92)

0.34 (0.28)

-1.56 (-3.22)

Immune System Disorders

41

0.31 (0.23–0.42)

0.31 (62.67)

0.31 (0.24)

-1.68 (-3.34)

Product Issues

41

0.21 (0.15–0.28)

0.21 (122.82)

0.21 (0.16)

-2.24 (-3.91)

Ear And Labyrinth Disorders

39

0.87 (0.63–1.19)

0.87 (0.8)

0.87 (0.67)

-0.21 (-1.87)

Congenital, Familial And Genetic Disorders

34

1.17 (0.84–1.64)

1.17 (0.87)

1.17 (0.89)

0.23 (-1.44)

Hepatobiliary Disorders

26

0.29 (0.2–0.43)

0.29 (45.25)

0.29 (0.21)

-1.78 (-3.45)

Reproductive System And Breast Disorders

22

0.32 (0.21–0.48)

0.32 (32.11)

0.32 (0.23)

-1.65 (-3.31)

Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)

18

0.05 (0.03–0.08)

0.05 (324.06)

0.05 (0.04)

-4.27 (-5.94)

Endocrine Disorders

7

0.25 (0.12–0.52)

0.25 (15.83)

0.25 (0.13)

-2 (-3.67)

Blood And Lymphatic System Disorders

6

0.03 (0.01–0.07)

0.03 (170.9)

0.03 (0.02)

-4.9 (-6.57)

  1. Asterisks (*) indicate statistically significant signals. Abbreviations: ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% confidence interval of EBGM; IC, information component; IC025, the lower limit of the 95% confidence interval of the IC