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Table 5 Incidence of adverse drug reactions

From: Safety and effectiveness of intravenous abatacept for polyarticular-course juvenile idiopathic arthritis: An all-case postmarketing surveillance study

Adverse drug reactions*

Safety analysis population

 

Overall (%)

n = 82

Continuously treated patients (%)

n = 17

Newly treated patients (%)

n = 65

Number of patients who experienced adverse drug reactions (%)

 

18

(22.0)

4

(23.5)

14

(21.5)

Number of adverse drug reactions

 

28

4

24

Infections and infestations

7

(8.5)

2

(11.8)

5

(7.7)

 

Acute sinusitis

1

(1.2)

0

(0.0)

1

(1.5)

 

Bronchitis

2

(2.4)

0

(0.0)

2

(3.1)

 

Gastroenteritis

1

(1.2)

0

(0.0)

1

(1.5)

 

Herpes simplex

1

(1.2)

1

(5.9)

0

(0.0)

 

Influenza

1

(1.2)

0

(0.0)

1

(1.5)

 

Nasopharyngitis

1

(1.2)

1

(5.9)

0

(0.0)

 

Otitis media acute

1

(1.2)

0

(0.0)

1

(1.5)

 

Pneumonia

1

(1.2)

0

(0.0)

1

(1.5)

 

Subcutaneous abscess

1

(1.2)

0

(0.0)

1

(1.5)

 

Varicella

1

(1.2)

0

(0.0)

1

(1.5)

 

Fungal esophagitis

1

(1.2)

0

(0.0)

1

(1.5)

Immune system disorders

1

(1.2)

0

(0.0)

1

(1.5)

 

Hypersensitivity

1

(1.2)

0

(0.0)

1

(1.5)

Eye disorders

 

1

(1.2)

1

(5.9)

0

(0.0)

 

Chalazion

1

(1.2)

1

(5.9)

0

(0.0)

Ear and labyrinth disorders

1

(1.2)

0

(0.0)

1

(1.5)

 

Ear discomfort

1

(1.2)

0

(0.0)

1

(1.5)

Respiratory, thoracic, and mediastinal disorders

2

(2.4)

0

(0.0)

2

(3.1)

 

Upper respiratory tract inflammation

2

(2.4)

0

(0.0)

2

(3.1)

Gastrointestinal disorders

4

(4.9)

0

(0.0)

4

(6.2)

 

Abdominal pain

1

(1.2)

0

(0.0)

1

(1.5)

 

Stomatitis

3

(3.7)

0

(0.0)

3

(4.6)

Skin and subcutaneous tissue disorders

1

(1.2)

0

(0.0)

1

(1.5)

 

Dry skin

1

(1.2)

0

(0.0)

1

(1.5)

 

Erythema

1

(1.2)

0

(0.0)

1

(1.5)

 

Perioral dermatitis

1

(1.2)

0

(0.0)

1

(1.5)

Musculoskeletal and connective tissue disorders

1

(1.2)

1

(5.9)

0

(0.0)

 

Arthritis

1

(1.2)

1

(5.9)

0

(0.0)

Investigations

3

(3.7)

0

(0.0)

3

(4.6)

 

Transaminases increased

1

(1.2)

0

(0.0)

1

(1.5)

 

Hepatic enzyme increased

1

(1.2)

0

(0.0)

1

(1.5)

 

Matrix metalloproteinase-3 increased

1

(1.2)

0

(0.0)

1

(1.5)

  1. *Adverse drug reactions were coded using MedDRA version 24.0