|
Drug related adverse events
| |
|
Clinical (total)
|
5 (8.3)
|
|
Fever
|
0 (0)
|
|
Pruritus
|
1 (1.7)
|
|
Nausea
|
3 (5.0)
|
|
Vomiting
|
1 (1.7)
|
|
Increase in alanine aminotransferase
| |
|
≥ 2.0 x normal value 39 U/L
|
10 (16.7)
|
|
≥ 3.0 x normal value 39 U/L
|
9 (15)
|
|
Increase in aspartate aminotransferase
| |
|
≥ 2.0 x normal value 59 U/L
|
1 (1.7)
|
|
≥ 3.0 x normal value 59 U/L
|
0 (0)
|
|
Increase in total bilirubin
| |
|
≥ 2.0 x normal value 1.1 mg/dl
|
0 (0)
|
|
≥ 3.0 x normal value 1.1 mg/dl
|
0 (0)
|
|
Increase in direct bilirubin
| |
|
≥ 2.0 x normal value 0.3 mg/dl
|
2 (3.4)
|
|
≥ 3.0 x normal value 0.3 mg/dl
|
0 (0)
|
|
Analysis of cyclosporin A level
|
(n = 28)
|
|
≥ 1.5 x baseline day 2-3
|
8 (28.6)
|
|
≥ 2.0 x baseline day 2-3
|
2 (7.1)
|
|
≥ 1.5 x baseline day 4-6
|
9 (32.1)
|
|
≥ 2.0 x baseline day 4-6
|
1 (3.6)
|
|
≥ 1.5 x baseline day 8-12
|
4 (14.3)
|
|
≥ 2.0 x baseline day 8-12
|
1 (3.6)
|
|
≥1.5 x baseline day 16-20
|
1 (3.6)
|
|
≥ 2.0 x baseline day 16-20
|
0 (0.0)
|
