Table 4.
Incidence of adverse events occurring in ≥10% in either arm of full analysis set and with a significant difference between treatment arms, no. (%).
| TAC/DAC | TAC/STR | |
|---|---|---|
| N = 67 | N = 68 | |
| Hepatitis C* | 28 (41.8) | 43 (63.2) |
| Hyperglycemia | 9 (13.4) | 13 (19.1) |
| Hyperkalemia | 8 (11.9) | 7 (10.3) |
| Anemia | 22 (32.8) | 21 (30.9) |
| Thrombocytopenia† | 19 (28.4) | 6 (8.8) |
| Leukopenia | 10 (14.9) | 15 (22.1) |
| Pancytopenia | 4 (6.0) | 7 (10.3) |
| Renal failure | 20 (29.9) | 23 (33.8) |
| Acute renal failure | 7 (10.4) | 6 (8.8) |
| Diarrhea | 9 (13.4) | 14 (20.6) |
| Ascites | 3 (4.5) | 8 (11.8) |
| Hypertension | 17 (25.4) | 20 (29.4) |
| Hypotension | 8 (11.9) | 9 (13.2) |
| Pleural effusion | 12 (17.9) | 15 (22.1) |
| Headache | 8 (11.9) | 8 (11.8) |
| Tremor | 9 (13.4) | 6 (8.8) |
| Peripheral edema | 7 (10.4) | 10 (14.7) |
| Insomnia | 7 (10.4) | 5 (7.4) |
| Back pain | 8 (11.9) | 9 (13.2) |
| Pruritus | 5 (7.5) | 7 (10.3) |
Not presented are adverse events related to the transplanted allograft or procedural complications.
*P = 0.016; † P = 0.004 (Fisher's exact test comparing the number of patients).