Adverse events in the first 6 months
| MMF (N=76) | TAC (N=74) | p Value | |
|---|---|---|---|
| Any adverse events | 59 (78%) | 69 (93%) | 0.007 |
| Death | 1 (1.3%) | 0 (0%) | 1.00 |
| Major infection (hospitalisation) | 7 (9.2%) | 4 (5.4%) | 0.53 |
| Minor infection (excluding Herpes) | 16 (28%) | 12 (16%) | 0.45 |
| Upper respiratory tract | 10 (13%) | 7 (9.5%) | 0.48 |
| Urinary tract | 3 (3.9%) | 1 (1.4%) | 0.62 |
| Gynaecological | 1 (1.3%) | 0 (0%) | 1.00 |
| Gastrointestinal | 0 (0%) | 1 (1.4%) | 1.00 |
| Sinusitis | 1 (1.3%) | 0 (0%) | 1.00 |
| Subcutaneous | 1 (1.3%) | 3 (4.1%) | 0.36 |
| Herpes zoster | 14 (18%) | 2 (2.7%) | 0.003 |
| Herpes simplex | 0 (0%) | 1 (1.4%) | 1.00 |
| Nausea | 3 (3.9%) | 2 (2.7%) | 1.00 |
| Diarrhoea | 8 (11%) | 2 (2.7%) | 0.10 |
| Diabetes mellitus | 2 (2.6%) | 3 (4.1%) | 0.68 |
| Alopecia | 0 (0%) | 6 (8.1%) | 0.01 |
| Tremor | 0 (0%) | 15 (20%) | <0.001 |
| Headache | 1 (1.3%) | 3 (4.1%) | 0.36 |
| Cramps | 2 (2.6%) | 7 (9.5%) | 0.10 |
| Tinnitus | 1 (1.3%) | 0 (0%) | 1.00 |
| Hypertrichosis | 0 (0%) | 1 (1.4%) | 1.00 |
| Reversible increase in SCr by 30% | 0 (0%) | 10 (14%) | 0.001 |
| Others | 4 (5.3%) | 1 (1.4%) | 0.37 |
MMF, mycophenolate mofetil; SCr, serum creatinine; TAC, tacrolimus.