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Table 2 Summary of AEs and SAEs in the RAPID 2 RCT and OLE (safety population, n = 612)

From: Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients

 

Patients, number (%)

Total number of events

Event rate per 100 PYsa

Incidence rate per 100 PYs

Total AEs

546 (89.2)

3789

163.0

87.4

Infections and infestationsb

420 (68.6)

1257

54.1

36.4

Tuberculosisc

6 (1.0)

6

0.26

0.26

Herpes zosterc

10 (1.6)

11

0.47

0.43

Neoplasms (benign, malignant and unspecified)b

19 (3.1)

20

0.9

0.8

Most frequent AEs by preferred term (ER >4.0 per 100 PYs)

Upper respiratory tract infections

93 (15.2)

154

6.6

4.4

Nasopharyngitis

67 (10.9)

101

4.3

3.1

Urinary tract infections

65 (10.6)

94

4.0

3.0

AEs leading to withdrawal

119 (19.4)

157

N/A

5.2

AEs leading to death by system organ class

19 (3.1)

25

N/A

0.8

Neoplasms (benign, malignant and unspecified)

5 (0.8)

5

N/A

0.2

Cardiac disorders

4 (0.7)

6

N/A

0.2

Nervous system disorders

4 (0.7)

4

N/A

0.2

Injury, poisoning and procedural complications

4 (0.7)

4

N/A

0.2

Infections and infestations

2 (0.3)

2

N/A

0.03

Hepatobiliary disorders

1 (0.2)

1

N/A

0.04

Musculoskeletal and connective tissue disorders

1 (0.2)

1

N/A

0.04

Total SAEs by system organ class

219 (35.8)

364

15.7

11.2

Infections/infestations

90 (14.7)

105

4.5

4.1

Musculoskeletal and connective tissue disorders

47 (7.7)

65

2.8

2.1

Neoplasms (benign, malignant and unspecified)

27 (4.4)

29

1.3

1.2

Injury, poisoning and procedural complications

23 (3.8)

25

1.1

1.0

  1. aEvent rates (ER) were not calculated when an adverse event (AE) occurred in individual patients only once (e.g., in the case of AEs leading to withdrawal or death); in these cases incidence rates are used; bMedDRA system organ class; cMedDRA preferred term. n/a not available, PYs patient-years, SAE serious adverse event