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Table 2 Adverse events (SOC with PT terms occurring in ≥2% of patients with at least one agent)

From: Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry

Exposure (Total, Mean pt.yrs)

IFX (n = 389)

GLM (n = 421)

1251, 3.2

675, 1.6

SOC/PT

N of Events

N of Patients

% of Patients

Rate/100 Pt-Yrs

N of Events

N of Patients

% of Patients

Rate/100 Pt-Yrs

TOTAL

1687

264

67.9%

136

882

297

70.5%

131

Eye disorders

65

40

10.3%

5.24

28

22

5.2%

4.15

 Uveitis

15

9

2.3%

1.21

13

9

2.1%

1.93

Gastrointestinal disorders

154

72

18.5%

12.4

56

39

9.3%

8.3

 Diarrhea

24

16

4.1%

1.93

13

12

2.9%

1.93

 Dyspepsia

10

9

2.3%

0.81

3

3

0.7%

0.44

 Nausea

27

19

4.9%

2.18

10

7

1.7%

1.48

 Vomiting

13

12

3.1%

1.05

4

4

1.0%

0.59

General disorders and administration site conditions

154

86

22.1%

12.4

176

156

37.1%

26.1

 Chest pain

18

13

3.3%

1.45

2

2

0.5%

0.3

 Chills

17

8

2.1%

1.37

1

1

0.2%

0.15

 Drug effect decreased

8

7

1.8%

0.64

27

26

6.2%

4.0

 Drug ineffective

12

12

3.1%

0.97

90

88

20.9%

13.3

 Fatigue

26

16

4.1%

2.10

10

9

2.1%

1.48

 Pain

21

16

4.1%

1.69

0

0

0

0

 Pyrexia

12

10

2.6%

0.97

6

5

1.2%

0.89

 Therapeutic response decreased

8

8

2.1%

0.64

25

25

5.9%

3.7

Infections and infestations

408

149

38.3%

32.9

309

129

30.6%

45.8

 Bronchitis

17

11

2.8%

1.37

16

16

3.8%

2.37

 Ear infection

11

11

2.8%

0.89

13

13

3.1%

1.93

 Gastroenteritis

17

15

3.9%

1.37

5

3

0.7%

0.74

 Influenza

15

15

3.9%

1.21

10

8

1.9%

1.48

 Nasopharyngitis

70

44

11.3%

5.64

59

31

7.4%

8.74

 Pneumonia

22

18

4.6%

1.77

8

8

1.9%

1.19

 Sinusitis

37

26

6.7%

2.98

27

18

4.3%

4.00

 Tooth abscess

8

8

2.1%

0.64

3

3

0.7

0.44

 Upper respiratory tract infection

36

28

7.2%

2.90

47

30

7.1%

1.33

 Urinary tract infection

34

19

4.9%

2.74

9

9

2.1%

1.33

Injury, poisoning and procedural complications

89

52

13.4%

7.17

29

25

5.9%

4.3

 Fall

12

10

2.6%

0.97

5

4

1.0%

0.74

 Infusion-related reaction

30

16

4.1%

2.42

0

0

0

0

Investigations

53

38

9.8%

4.27

10

10

2.4%

1.48

 Hepatic enzyme increased

12

11

2.8%

0.97

3

3

0.7%

0.44

Musculoskeletal and connective tissue disorders

263

80

20.6%

21.2

65

45

10.7%

9.63

 Ankylosing spondylitis

11

10

2.6%

0.89

2

2

0.5%

0.30

 Arthralgia

62

31

8.0%

5.00

9

7

1.7%

1.33

 Back pain

53

28

7.2%

4.27

9

9

2.1%

1.33

 Musculoskeletal pain

10

8

2.1%

0.81

2

2

0.5%

0.3

 Neck pain

18

14

3.6%

1.45

3

3

0.7%

0.44

 Pain in extremity

38

20

5.1%

3.06

8

8

1.9%

1.19

Nervous system disorders

80

46

11.8%

6.45

34

29

6.9%

5.04

 Headache

27

21

5.4%

2.18

8

7

1.7%

1.19

 Hypoaesthesia

22

12

3.1%

1.77

2

2

0.5%

0.3

Respiratory, thoracic and mediastinal disorders

99

56

14.4%

7.98

27

19

4.5%

4.00

 Cough

20

17

4.4%

1.61

7

7

1.7%

1.04

 Dyspnoea

12

11

2.8%

0.97

0

0

0

0

 Oropharyngeal pain

22

12

3.1%

1.77

6

5

1.2%

0.89

Skin and subcutaneous tissue disorders

119

63

16.2%

9.59

59

39

9.3%

8.74

 Pruritus

24

19

4.9%

1.93

0

0

0

0

 Psoriasis

15

8

2.1%

1.21

12

9

2.1%

1.33

 Rash

16

12

3.1%

1.29

9

9

2.1%

1.33

Vascular disorders

50

30

7.7%

4.03

9

8

1.9%

1.33

 Hypertension

20

15

3.9%

1.61

6

6

1.4%

0.89