Table 2

Summary of adverse events in all patients treated with CZP in the RAPID 1 RCT and OLE (safety population)

Adverse eventNo. of Pts (%)* N=958Total number of eventsEvent rate (ER) per 100 patient-yearsIncidence rate per 100 patient-years
Total AEs899 (93.8)10 838290.4144.0
Neoplasms (benign, malignant and unspecified)†87 (9.1)1052.82.4
Infections/Infestations†717 (74.8)313083.949.0
Most frequent infections by preferred term (ER>7.0 per 100 pt-yrs)
 Upper respiratory tract144 (15.0)2747.34.3
 Nasopharyngitis162 (16.9)2737.34.9
 Urinary tract infections161 (16.8)2957.94.9
AEs leading to withdrawal177 (18.5)1874.8
AEs leading to death21 (2.2)250.6
Total SAEs399 (41.6)75720.313.5
Serious infections/infestations†159 (16.6)2195.94.6
Most frequent SAEs by preferred term (ER>0.25 per 100 pt-yrs)
 Pneumonia34 (3.5)361.00.9
 Cellulitis12 (1.3)130.40.3
 Cholelithiasis11 (1.1)110.30.3
  • *Patients who experienced more than one AE in a category are only listed once.

  • †MedDRA system organ class.

  • AE, adverse events; CZP, certolizumab pegol; OLE, open-label extension; pt-yrs, patient-years; RAPID, Rheumatoid Arthritis Prevention of Structural Damage; RCT, randomised controlled trial.