Table 4.
Adverse effects | 0 | 1+ | 2+ | 3+ | Overall frequency (as %) |
---|---|---|---|---|---|
Vomiting |
30 / 27 |
0 / 1 |
0 / 0 |
NA |
0 / 3.57 |
Diarrhea |
28 / 20 |
2 / 8 |
0 / 0 |
NA |
6.67 / 28.6 |
Dyspepsia |
19 / 14 |
9 / 5 |
2 / 9 |
0 / 0 |
36.7 / 50.0 |
Acid suppressive therapy |
12 / 9 |
18 / 16 |
0 / 3 |
NA |
60.0 / 67.9 |
Acne b |
26 / 21 |
4 / 4 |
0 / 3 |
0 / 0 |
13.3 / 25.0 |
Skin changes |
21 / 21 |
8 / 5 |
1 / 2 |
0 / 0 |
30.0 / 25.0 |
Hirsutism |
22 / 22 |
7 / 3 |
1 / 3 |
0 / 0 |
26.7 / 21.4 |
Moon facies |
13 / 17 |
15 / 11 |
2 / 0 |
0 / 0 |
56.7 / 39.3 |
Gingival hyperplasia |
7 / 22 |
21 / 6 |
2 / 0 |
NA |
76.7 / 21.4 |
Buffalo humpc |
21 / 22 |
9 / 6 |
NA |
NA |
30.0 / 21.4 |
Tremor |
13 / 7 |
15 / 16 |
2 / 4 |
0 / 1 |
56.7 / 75.0 |
Headachec |
28 / 22 |
2 / 6 |
NA |
NA |
6.67 / 21.4 |
Insomnia |
22 / 15 |
5 / 9 |
2 / 4 |
1 / 0 |
26.7 / 46.4 |
Myopathy |
27 / 24 |
2 / 4 |
1 / 0 |
0 / 0 |
10.0 / 14.3 |
Ophthalmic changesc |
17 / 18 |
13 / 10 |
NA |
NA |
43.3 / 35.7 |
Mania |
29 / 28 |
1 / 0 |
0 / 0 |
NA |
3.33 / 0 |
Depression |
26 / 18 |
4 / 4 |
0 / 6 |
0 / 0 |
13.3 / 35.7 |
Post-transplant diabetes mellitusc | 21 / 19 | 9 / 9 | NA | NA | 30.0 / 32.1 |
Data displayed as cyclosporine and MMF regimen (n = 30) / tacrolimus and EC-MPS regimen (n = 28).
aSeverity score determined using Tables 1 and 2; bNo patients received a 4+ for acne; c rated as present or absent.
NA, non-applicable since no rating; MMF, mycophenolate mofetil; EC-MPS, enteric coated mycophenolate sodium.