Table 4.
Commonly reporteda adverse events—number (%) of patients.
| Tacrolimus/Sirolimus N = 318 | Tacrolimus/MMF N = 316 | |
|---|---|---|
| Adverse event | ||
| Metabolism or nutrition | 167 (52.5) | 156 (49.4) |
| Hyperglycemia | 38 (11.9) | 46 (14.6) |
| Diabetes mellitus | 25 (7.9) | 32 (10.1) |
| Hyperkalemiab | 15 (4.7) | 28 (8.9) |
| Hypercholesterolemiab | 35 (11.0) | 18 (5.7) |
| Infections | 149 (46.9) | 162 (51.3) |
| Urinary tract | 83 (26.1) | 83 (26.3) |
| Cytomegalovirusc | 9 (2.8) | 38 (12.0) |
| Nasopharyngitisb | 7 (2.2) | 19 (6.0) |
| Blood and lymphatic systemb | 76 (23.9) | 102 (32.6) |
| Anemia | 52 (16.4) | 68 (21.5) |
| Leukopeniac | 5 (1.6) | 27 (8.5) |
| Gastrointestinal disorders | 83 (26.1) | 90 (28.5) |
| Diarrheab | 38 (11.9) | 57 (18.0) |
| Vascular disorders | 74 (23.3) | 54 (17.1) |
| General or site of drug administration | 65 (20.4) | 50 (15.8) |
| Peripheral edemab | 22 (6.9) | 10 (3.2) |
| Nervous system | 44 (13.8) | 45 (14.2) |
| Musculoskeletal | 42 (13.2) | 31 (9.8) |
|
| ||
| Serious Adverse Event | ||
| Infection | 48 (15.1) | 37 (11.7) |
| Cytomegalovirus infectionc | 3 (0.9) | 16 (5.1) |
| Vascular disorders | 23 (7.2) | 14 (4.4) |
| Gastrointestinal disorders | 17 (5.3) | 16 (5.1) |
| Cardiac disordersb | 2 (0.6) | 10 (3.2) |
FAS
aListed are the most common adverse events occurring in ≥10% of patients or with a significant difference between groups. Serious adverse events are listed if they occurred in ≥5% of patients. Reports of renal dysfunction/impairment, surgical complications, and abnormal laboratory values are not presented here as an adverse event.
b P < .05. c P < .001 (Fisher's exact test for all comparisons).