Table 5.
Patients with serious adverse events in RTR-PD subpopulation
| Serious Adverse Events, n (%) | Belatacept MI (n = 114) | Belatacept LI (n = 97) | CsA (n = 125) |
|---|---|---|---|
| All adverse events | 113 (99.1) | 97 (100) | 124 (99.2) |
| Total serious adverse events | 69 (60.5) | 53 (54.6) | 84 (67.2) |
| infections and infestations | 34 (29.8) | 20 (20.6) | 38 (30.4) |
| injury, poisoning, and procedural complications of transplanted kidney | 14 (12.3) | 16 (16.5) | 19 (15.2) |
| renal and urinary disorders | 13 (11.4) | 9 (9.3) | 26 (20.8) |
| gastrointestinal disorders | 12 (10.5) | 6 (6.2) | 10 (8.0) |
| general disorders and administration site conditions | 11 (9.6) | 5 (5.2) | 13 (10.4) |
| cardiac disorders | 10 (8.8) | 4 (4.1) | 13 (10.4) |
| investigations | 9 (7.9) | 6 (6.2) | 12 (9.6) |
| vascular disorders | 9 (7.9) | 6 (6.2) | 17 (13.6) |
| blood and lymphatic system disorders | 8 (7.0) | 2 (2.1) | 7 (5.6) |
| metabolism and nutrition disorders | 5 (4.4) | 4 (4.1) | 7 (5.6) |
| nervous system disorders | 5 (4.4) | 0 (0) | 4 (3.2) |
| respiratory, thoracic, and mediastinal disorders | 5 (4.4) | 4 (4.1) | 5 (4.0) |
| neoplasms: benign, malignant, and unspecified (includes cysts and polyps) | 4 (3.5) | 3 (3.1) | 7 (5.6) |
| reproductive system and breast disorders | 3 (2.6) | 0 (0) | 2 (1.6) |
| eye disorders | 2 (1.8) | 0 (0) | 0 (0) |
| musculoskeletal and connective tissue disorders | 2 (1.8) | 0 (0) | 0 (0) |
| skin and subcutaneous tissue disorders | 2 (1.8) | 1 (1.0) | 2 (1.6) |
| congenital, familial, and genetic disorders | 1 (0.9) | 0 (0) | 0 (0) |
| endocrine disorders | 0 (0) | 0 (0) | 1 (0.8) |
| hepatobiliary disorders | 0 (0) | 1 (1.0) | 0 (0) |
There were no significant differences between belatacept and cyclosporine groups. CsA, cyclosporine; LI, less intensive; MI, more intensive; RTR-PD, renal transplant recipients with preexisting diabetes.