Table 5. Summary of severe (grade 3 or 4) adverse events, including laboratory abnormalities, by body system.
|
rIL-2 regimen |
|||||
|---|---|---|---|---|---|
| s.c. | c.i.v. | ||||
| Body system | (n=103) | % | (n=225) | % | P-value |
| Any adverse event | 47 | 46 | 171 | 76 | <0.001 |
| Body as a whole | 26 | 25 | 73 | 32 | 0.19 |
| Cardiovascular system | 3 | 3 | 78 | 39 | <0.001 |
| Digestive system | 9 | 9 | 30 | 13 | 0.23 |
| Endocrine system | 1 | 1 | 0 | 0 | 0.31 |
| Eye | 0 | 0 | 1 | <1 | 1.0 |
| Haemic and lymphatic system | 10 | 10 | 22 | 10 | 0.98 |
| Metabolic and nutritional disorders | 10 | 10 | 54 | 24 | 0.002 |
| Musculoskeletal system | 1 | 1 | 2 | 1 | 1.0 |
| Nervous system | 1 | 1 | 28 | 12 | <0.001 |
| Not specified | 0 | 0 | 1 | <1 | 1.0 |
| Respiratory system | 0 | 0 | 31 | 14 | <0.001 |
| Skin and appendages | 4 | 4 | 17 | 8 | 0.21 |
| Urogenital system | 3 | 3 | 24 | 11 | 0.018 |
| Injection site | 5 | 5 | 0 | 0 | 1.0 |
s.c.=subcutaneous; c.i.v.=continuous intravenous infusion.