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Table 2 Signal strength of reports at the system organ class (SOC) level

From: Assessment the real-world safety of intravitreal dexamethasone implant (Ozurdex): novel insights from a comprehensive pharmacovigilance analysis utilizing the FAERS database

SOC

Case Reports

ROR (95% CI)

PRR (95% CI)

Chisq

IC (IC025)

EBGM (EBGM05)

Eye Disorders

1761

45.11 (42.26, 48.14)

23.71 (22.8, 24.66)

39032.71

4.56 (4.48)

23.67 (22.41)

Infections and Infestations

351

1.84 (1.65, 2.06)

1.76 (1.6, 1.94)

122.54

0.82 (0.66)

1.76 (1.61)

Injury, Poisoning and Procedural Complications

561

1.65 (1.5, 1.8)

1.55 (1.43, 1.68)

120.15

0.63 (0.5)

1.55 (1.43)

Investigations

204

0.93 (0.8, 1.07)

0.93 (0.81, 1.07)

1.12

-0.1 (-0.31)

0.93 (0.83)

Surgical and Medical Procedures

41

0.81 (0.59, 1.1)

0.81 (0.59, 1.11)

1.85

-0.3 (-0.74)

0.81 (0.63)

General Disorders and Administration Site Conditions

458

0.65 (0.59, 0.71)

0.69 (0.64, 0.75)

77.74

-0.53 (-0.67)

0.69 (0.64)

Pregnancy, Puerperium and Perinatal Conditions

9

0.59 (0.3, 1.13)

0.59 (0.31, 1.13)

2.64

-0.77 (-1.67)

0.59 (0.34)

Endocrine Disorders

4

0.42 (0.16, 1.12)

0.42 (0.16, 1.12)

3.17

-1.24 (-2.51)

0.42 (0.19)

Vascular Disorders

31

0.39 (0.27, 0.56)

0.4 (0.28, 0.57)

29.16

-1.34 (-1.84)

0.4 (0.29)

Cardiac Disorders

19

0.2 (0.13, 0.32)

0.21 (0.13, 0.33)

59.01

-2.27 (-2.9)

0.21 (0.14)

Nervous System Disorders

65

0.19 (0.15, 0.25)

0.21 (0.17, 0.27)

213.09

-2.26 (-2.61)

0.21 (0.17)

Immune System Disorders

8

0.19 (0.09, 0.37)

0.19 (0.1, 0.38)

28.13

-2.4 (-3.35)

0.19 (0.11)

Metabolism and Nutrition Disorders

12

0.15 (0.09, 0.26)

0.15 (0.08, 0.26)

57.47

-2.71 (-3.49)

0.15 (0.1)

Neoplasms Benign, Malignant and Unspecified

14

0.13 (0.08, 0.22)

0.13 (0.08, 0.22)

80.73

-2.9 (-3.63)

0.13 (0.09)

Renal and Urinary Disorders

9

0.13 (0.07, 0.24)

0.13 (0.07, 0.25)

54.03

-2.96 (-3.85)

0.13 (0.07)

Psychiatric Disorders

21

0.09 (0.06, 0.15)

0.1 (0.06, 0.15)

180.13

-3.32 (-3.92)

0.1 (0.07)

Respiratory, Thoracic and Mediastinal Disorders

15

0.08 (0.05, 0.13)

0.08 (0.05, 0.13)

155.43

-3.56 (-4.27)

0.08 (0.06)

Blood and Lymphatic System Disorders

5

0.08 (0.03, 0.19)

0.08 (0.03, 0.19)

53.09

-3.63 (-4.78)

0.08 (0.04)

Musculoskeletal and Connective Tissue Disorders

13

0.06 (0.04, 0.11)

0.07 (0.04, 0.12)

184.72

-3.94 (-4.7)

0.07 (0.04)

Gastrointestinal Disorders

15

0.04 (0.03, 0.07)

0.05 (0.03, 0.08)

316.0

-4.4 (-5.11)

0.05 (0.03)

Skin and Subcutaneous Tissue Disorders

6

0.03 (0.01, 0.06)

0.03 (0.01, 0.07)

203.25

-5.09 (-6.15)

0.03 (0.02)