Variable | No. (%) (n = 60) |
---|---|
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) |