Table 2.
Summary of adverse events (AEs) in all patients treated with CZP in the RCTs or OLE (safety population)
| Event Primary system organ class High level term Preferred Term |
Event rate per 100 PY Safety population (N = 427) |
|---|---|
| AEs leading to death | 0.6 |
| AEs leading to withdrawal | 7.8 |
| Infections and infestations | 2.3 |
| Any AEa | 408.1 |
| Infections and infestations | 112.2 |
| Tuberculosis | 0.2 |
| Candida infection (including topical) | 1.1 |
| Herpes viral infections | 5.6 |
| Herpes simplex | 4.0 |
| Herpes zoster | 1.6 |
| Injection and infusion site reactions | 3.6 |
| Injection site reaction | 1.1 |
| Injection site pain | 0.5 |
| Any serious AE (SAEs) | 25.2 |
| Infections and infestations | 4.5 |
| Cardiac disorders | 2.2 |
| Neoplasmsb | 1.6 |
Safety population included all patients who received CZP in either the RCT or OLE. MedDRA version 9.0
a43.6% of AEs for the safety population were classed as severe in intensity
bNeoplasms could be benign, malignant, or unspecified (includes cysts and polyps)