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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