Table 3.
Adverse events (AEs) occurring in ≥20% of patients in any group, or those AEs of particular interest.
| Events | Low-dose Tac group (Group A), (N = 151) n (%) |
Standard-dose Tac group (Group B), (N = 141) n (%) |
|---|---|---|
| Any serious adverse event | 73 (48.3) | 67 (47.5) |
| Any infection | 90 (59.6) | 89 (63.1) |
| Bacterial | 59 (39.1) | 65 (46.1) |
| Viral | 33 (21.9) | 27 (19.1) |
| Any adverse event | 145 (96.0) | 138 (97.9) |
| Diarrhea | 61 (40.4) | 61 (43.3) |
| Nausea | 47 (31.1) | 47 (33.3) |
| Constipation | 47 (31.1) | 46 (32.6) |
| Urinary tract infection | 43 (28.5) | 44 (31.2) |
| Anemia | 38 (25.2) | 46 (32.6) |
| Procedural pain | 31 (20.5) | 33 (23.4) |
| Edema peripheral | 34 (22.5) | 25 (17.7) |
| Insomnia | 21 (13.9) | 32 (22.7) |
| Tremor | 18 (11.9) | 29 (20.6)1 |
1 P = 0.045 compared to Group A.