Table 3.
Frequencies and incidence rates of SAEs that occurred in two or more patients in any group by category
| Parameter | Belatacept |
CsA |
||
|---|---|---|---|---|
| % (n = 102) | Incidence Rate/100 patient-years (95% CI) | % (n = 26) | Incidence Rate/100 patient-years (95% CI) | |
| Infections to total | 16 | 4.0 (2.3 to 6.5) | 27 | 7.1 (2.8 to 14.6) |
| UTI | 4 | 1.0 (0.3 to 2.6) | 12 | 3.4 (0.7 to 9.9) |
| pneumonia | 3 | 0.8 (0.2 to 2.2) | 0 | 0.0 (0.0 to 3.7) |
| pyelonephritis | 2 | 0.5 (0.1 to 1.8) | 4 | 1.0 (0.0 to 5.7) |
| gastroenteritis | 2 | 0.5 (0.1 to 1.8) | 4 | 1.1 (0.0 to 5.9) |
| Neoplasms to total | 12 | 3.0 (1.5 to 5.2) | 12 | 3.0 (0.6 to 8.9) |
| basal cell carcinoma | 4 | 1.0 (0.3 to 2.6) | 4 | 1.0 (0.0 to 5.8) |
| squamous cell carcinoma | 2 | 0.5 (0.1 to 1.8) | 4 | 1.0 (0.0 to 5.7) |
| breast cancer | 2 | 0.5 (0.1 to 1.8) | 0 | 0.0 (0.0 to 3.7) |
| Gastrointestinal disorders to total | 12 | 3.0 (1.5 to 5.2) | 8 | 2.0 (0.2 to 7.3) |
| diarrhea | 4 | 1.0 (0.3 to 2.6) | 4 | 1.0 (0.0 to 5.8) |
| abdominal pain | 2 | 0.5 (0.1 to 1.8) | 0 | 0.0 (0.0 to 3.7) |
| pancreatitis | 2 | 0.5 (0.1 to 1.8) | 0 | 0.0 (0.0 to 3.7) |
| General disorders to total | 3 | 0.7 (0.2 to 2.2) | 4 | 1.0 (0.0 to 5.6) |
| pyrexia | 2 | 0.5 (0.1 to 1.8) | 4 | 1.0 (0.0 to 5.8) |
| Cardiac disorders to total | 2 | 0.5 (0.1 to 1.8) | 12 | 3.0 (0.6 to 8.9) |
| coronary artery stenosis | 0 | 0.0 (0.0 to 0.9) | 8 | 2.1 (0.3 to 7.5) |
CI, confidence interval.