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Table 5 Adverse events (preferred term; ≥2 patients with one agent)

From: Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

 

IFX (N = 890)

GLM (N = 530)

GLM-IV (N = 157)

N of Events

N of Patients

% of Patients

Rate/100 Pt-Yrs

N of Events

N of Patients

% of Patients

Rate/100 Pt-Yrs

N of Events

N of Patients

% of Patients

Rate/100 Pt-Yrs

Gastrointestinal disorders

 Diarrhea

27

20

2.2%

0.94

12

12

2.3%

1.11

1

1

0.6%

0.39

 Nausea

54

44

4.9%

1.87

13

12

2.3%

1.21

2

2

1.3%

0.78

 Vomiting

23

20

2.2%

0.80

7

7

1.3%

0.65

1

1

0.6%

0.39

General disorders and administration site conditions

 Chest discomfort

26

22

2.5%

0.90

0

0

0

0

0

0

0

0

 Chest pain

21

19

2.1%

0.73

2

2

0.4%

0.19

1

1

0.6%

0.39

 Drug effect decreased

5

5

0.6%

0.17

22

22

4.2%

2.04

6

6

3.8%

2.34

 Drug ineffective

19

19

2.1%

0.66

64

63

11.9%

5.94

23

23

14.6%

8.96

 Fatigue

41

33

3.7%

1.42

5

5

0.9%

0.46

3

3

1.9%

1.17

 Influenza-like illness

15

11

1.2%

0.52

16

15

2.8%

1.49

3

3

1.9%

1.17

 Pain

23

20

2.2%

0.80

3

3

0.6%

0.28

0

0

0

0

 Pyrexia

27

26

2.9%

0.94

4

4

0.8%

0.37

1

1

0.6%

0.39

 Therapeutic response decreased

22

22

2.5%

0.76

23

23

4.3%

2.14

1

1

0.6%

0.39

Infections and infestations

 Bronchitis

51

41

4.6%

1.77

18

17

3.2%

1.67

5

5

3.2%

1.95

 Ear infection

21

14

1.6%

0.73

11

10

1.9%

1.02

4

4

2.5%

1.56

 Herpes Zoster

19

19

2.1%

0.66

14

13

2.5%

1.3

1

1

0.6%

0.39

 Influenza

36

29

3.3%

1.25

13

10

2.1%

1.21

0

0

0

0

 Pneumonia

47

41

4.6%

1.63

13

11

2.1%

1.21

2

2

1.3%

0.78

 Sinusitis

53

31

3.5%

1.84

14

13

2.5%

1.3

8

6

3.8%

3.12

 Upper respiratory tract infection

72

49

5.5%

2.49

57

45

8.5%

5.29

3

3

1.9%

1.17

 Urinary tract infection

51

32

3.6%

1.77

32

23

4.3%

2.97

6

6

3.8%

2.34

Injury, poisoning and procedural complications

178

108

12.1%

6.17

56

36

6.8%

5.2

17

11

7.0%

6.62

 Fall

24

21

2.4%

0.83

9

9

1.7%

0.84

9

4

2.5%

3.51

 Infusion-related reaction

53

37

4.2%

1.84

0

0

0

0

0

0

0

0

Musculoskeletal and connective tissue disorders

486

152

17.1%

16.8

130

84

15.8%

12.1

17

11

7.0%

6.62

 Arthralgia

150

60

6.7%

5.20

24

19

3.6%

2.23

5

5

3.2%

1.95

 Back pain

30

26

2.9%

1.04

7

6

1.1%

0.65

0

0

0

0

 Pain in extremity

65

30

3.4%

2.25

4

4

0.8%

0.37

2

2

1.3%

0.78

 Osteoarthritis

26

18

2.0%

0.90

17

14

2.6%

1.58

0

0

0

0

 Rheumatoid arthritis

57

37

4.2%

1.97

18

16

3.0%

1.67

3

3

1.9%

1.17

Nervous system disorders

166

107

12.0%

5.75

64

48

9.1%

5.94

8

6

3.8%

3.12

 Dizziness

29

23

2.6%

1.00

5

5

0.9%

0.46

1

1

0.6%

0.39

 Headache

61

44

4.9%

2.11

10

11

1.9%

1.02

1

1

0.6%

0.39

Respiratory, thoracic and mediastinal disorders

226

131

14.7%

7.83

73

44

8.3%

6.78

15

10

6.4%

5.84

 Cough

40

28

3.1%

1.39

21

16

3.0%

1.95

3

3

1.9%

1.17

Skin and subcutaneous tissue disorders

260

160

18.0%

9.01

83

57

10.8%

7.71

14

11

7.0%

5.45

 Pruritus

35

32

3.6%

1.21

2

2

0.4%

0.19

1

1

0.6%

0.39

 Psoriasis

10

9

1.0%

0.35

16

11

2.1%

1.49

1

1

0.6%

0.39

 Rash

39

32

3.6%

1.35

15

15

2.8%

1.39

2

1

0.6%

0.39

Vascular disorders

90

63

7.1%

3.12

14

14

2.6%

1.3

1

1

0.6%

0.39

 Hypertension

27

22

2.5%

0.94

5

5

0.9%

0.46

0

0

0

0