Summary of adverse events in all patients treated with CZP in the RAPID 1 RCT and OLE (safety population)
| Adverse event | No. of Pts (%)* N=958 | Total number of events | Event rate (ER) per 100 patient-years | Incidence rate per 100 patient-years |
|---|---|---|---|---|
| Total AEs | 899 (93.8) | 10 838 | 290.4 | 144.0 |
| Neoplasms (benign, malignant and unspecified)† | 87 (9.1) | 105 | 2.8 | 2.4 |
| Infections/Infestations† | 717 (74.8) | 3130 | 83.9 | 49.0 |
| Most frequent infections by preferred term (ER>7.0 per 100 pt-yrs) | ||||
| Upper respiratory tract | 144 (15.0) | 274 | 7.3 | 4.3 |
| Nasopharyngitis | 162 (16.9) | 273 | 7.3 | 4.9 |
| Urinary tract infections | 161 (16.8) | 295 | 7.9 | 4.9 |
| AEs leading to withdrawal | 177 (18.5) | 187 | – | 4.8 |
| AEs leading to death | 21 (2.2) | 25 | – | 0.6 |
| Total SAEs | 399 (41.6) | 757 | 20.3 | 13.5 |
| Serious infections/infestations† | 159 (16.6) | 219 | 5.9 | 4.6 |
| Most frequent SAEs by preferred term (ER>0.25 per 100 pt-yrs) | ||||
| Pneumonia | 34 (3.5) | 36 | 1.0 | 0.9 |
| Cellulitis | 12 (1.3) | 13 | 0.4 | 0.3 |
| Cholelithiasis | 11 (1.1) | 11 | 0.3 | 0.3 |
*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.