Table 3.
Most common AEs (>10%), serious AEs (>3%), and malignancies at 24 months
| Variable | Belatacept Conversion, n=221 | CNI Continuation, n=222 |
|---|---|---|
| AEs | 211 (95%) | 204 (92%) |
| Diarrhea | 48 (22%) | 63 (28%) |
| Nasopharyngitis | 44 (20%) | 50 (23%) |
| Urinary tract infection | 42 (19%) | 34 (15%) |
| Cough | 31 (14%) | 20 (9%) |
| Hypertension | 29 (13%) | 21 (9%) |
| Headache | 27 (12%) | 23 (10%) |
| Bronchitis | 23 (10%) | 18 (8%) |
| Peripheral edema | 22 (10%) | 35 (16%) |
| Arthralgia | 21 (10%) | 23 (10%) |
| Serious AEs | 107 (48%) | 95 (43%) |
| Kidney transplant rejectiona | 19 (9%) | 7 (3%) |
| Basal cell carcinoma | 11 (5%) | 5 (2%) |
| Urinary tract infection | 7 (3%) | 7 (3%) |
| Pneumonia | 5 (2%) | 7 (3%) |
| Major categories of serious AEs | ||
| Any serious infection | 37 (17%) | 44 (20%) |
| Any serious viral infection | 5 (2%) | 9 (4%) |
| Influenza | 2 (1%) | 2 (1%) |
| BK virus infection | 1 (<1%) | 2 (1%) |
| CMV infection | 0 | 2 (1%) |
| Gastroenteritis norovirus | 1 (<1%) | 1 (<1%) |
| Herpes zoster | 2 (1%) | 0 |
| Gastroenteritis rotavirus | 0 | 1 (<1%) |
| Gastroenteritis viral | 0 | 1 (<1%) |
| Pneumonia respiratory syncytial viral | 0 | 1 (<1%) |
| Any serious fungal infection | 0 | 1 (<1%)b |
| Any malignancy, excluding PTLD | 17 (8%) | 12 (5%) |
| All malignancies, n (%) | ||
| Basal cell carcinoma | 11 (5%) | 5 (2%) |
| Squamous cell carcinoma of skin | 4 (2%) | 1 (<1%) |
| Squamous cell carcinoma | 3 (1%) | 5 (2%) |
| Bowen disease | 2 (1%) | 1 (<1%) |
| Prostate cancer, including recurrence | 1 (<1%) | 1 (<1%) |
| PTLDc | 1 (<1%) | 0 |
| Papillary thyroid carcinoma | 1 (<1%) | 0 |
| Lung adenocarcinoma | 0 | 1 (<1%) |
Data are n (%).
a
Not based on AE records; not all biopsies were reported as serious AEs.
b
Patient experienced disseminated histoplasmosis, which resulted in death.
c
Patient developed non-CNS PTLD, received chemotherapy, and completed the study with a functioning graft.