Table 5. Treatment-emergent adverse events (safety population) during 24 weeks after CZP initiation.
| Adverse events |
J-RAPID |
HIKARI |
||
|---|---|---|---|---|
| Event rates per 100 patient-years | LD (n = 82) | No-LD (n = 61) | LD (n = 116) | No-LD (n = 99) |
| Total exposure (patient-years) | 37.251 | 27.751 | 52.504 | 44.950 |
| Any adverse events | 359.72 | 479.26 | 447.59 | 444.94 |
| Infections and infestations | 107.38 | 158.55 | 102.85 | 131.26 |
| Bronchitis | 0 | 10.81 | 3.81 | 11.12 |
| Nasopharyngitis | 32.21 | 50.45 | 43.81 | 24.47 |
| Pharyngitis | 10.74 | 7.21 | 11.43 | 8.90 |
| Upper respiratory tract infection | 5.37 | 25.22 | 7.62 | 4.45 |
| Any serious adverse events a | 13.42 | 28.83 | 20.95 | 24.47 |
| Serious infections and infestations | 10.74 | 14.41 | 7.62 | 4.45 |
| Injection site reaction | 2.68 | 46.85 | 53.33 | 37.82 |
| Malignancies | 0 | 0 | 0 | 0 |
| AE leading to death | 0 | 0 | 0 | 0 |
AE, adverse event; LD, Loading dose.
a
Serious adverse events were those that resulted in death, were life-threatening, required or prolonged hospitalization, or resulted in significant disability or incapacity or were congenital anomalies/birth defects.