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 events113 (99.1)97 (100)124 (99.2)
Total serious adverse events69 (60.5)53 (54.6)84 (67.2)
    infections and infestations34 (29.8)20 (20.6)38 (30.4)
    injury, poisoning, and procedural complications of transplanted kidney14 (12.3)16 (16.5)19 (15.2)
    renal and urinary disorders13 (11.4)9 (9.3)26 (20.8)
    gastrointestinal disorders12 (10.5)6 (6.2)10 (8.0)
    general disorders and administration site conditions11 (9.6)5 (5.2)13 (10.4)
    cardiac disorders10 (8.8)4 (4.1)13 (10.4)
    investigations9 (7.9)6 (6.2)12 (9.6)
    vascular disorders9 (7.9)6 (6.2)17 (13.6)
    blood and lymphatic system disorders8 (7.0)2 (2.1)7 (5.6)
    metabolism and nutrition disorders5 (4.4)4 (4.1)7 (5.6)
    nervous system disorders5 (4.4)0 (0)4 (3.2)
    respiratory, thoracic, and mediastinal disorders5 (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 disorders3 (2.6)0 (0)2 (1.6)
    eye disorders2 (1.8)0 (0)0 (0)
    musculoskeletal and connective tissue disorders2 (1.8)0 (0)0 (0)
    skin and subcutaneous tissue disorders2 (1.8)1 (1.0)2 (1.6)
    congenital, familial, and genetic disorders1 (0.9)0 (0)0 (0)
    endocrine disorders0 (0)0 (0)1 (0.8)
    hepatobiliary disorders0 (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.