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| |
Baseline
|
Worst post-baseline value
|
|---|
|
ALT (U/L)
|
n (%)
|
≤ ULN, n (%)
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> ULN to ≤ 5 × ULN, n (%)
|
> 5 × ULN, n (%)
|
Notable range, n (%)
|
Extended range, n (%)
|
|---|
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≤ ULN
|
34 (64.2)
|
19 (55.9)
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14 (41.2)
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0
|
0
|
1 (2.9)
|
|
> ULN to ≤ 5 × ULN
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19 (35.8)
|
0
|
17 (89.5)
|
0
|
2 (10.5)
|
0
|
|
Total
|
53 (100.0)
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19 (35.8)
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31 (58.5)
|
0
|
2 (3.8)
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1 (1 .9)
|
|
AST (U/L)
|
n (%)
|
≤ ULN, n (%)
|
> ULN to ≤ 5 × ULN, n (%)
|
> 5 × ULN, n (%)
|
Notable range, n (%)
|
Extended range, n (%)
|
|---|
|
≤ ULN
|
41 (77.4)
|
23 (56.1)
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17 (41.5)
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0
|
0
|
1 (2.4)
|
|
> ULN to ≤ 5 × ULN
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12 (22.6)
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0
|
12 (100.0)
|
0
|
0
|
0
|
|
Total
|
53 (100.0)
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23 (43.4)
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29 (54.7)
|
0
|
0
|
1 (1.9)
|
|
Serum creatinine
|
n (%)
|
≤ ULN, n (%)
|
Two consecutive > ULN, n (%)
|
Notable range, n (%)
|
Missing, n (%)
| |
|---|
|
≤ ULN
|
53 (100.0)
|
51 (96.2)
|
2 (3.8)
|
0
|
0
| |
|
Total
|
53 (100.0)
|
51 (96.2)
|
2 (3.8)
|
0
|
0
| |
|
Creatinine clearance
|
n (%)
|
≥ 60, n (%)
|
One value ≥ 40 to < 60, n (%)
|
Notable range, n (%)
|
One value < 40, n (%)
|
Extended range, n (%)
|
|---|
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≥ 60
|
50 (94.3)
|
45 (90.0)
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2 (4.0)
|
1 (2.0)
|
2 (4.0)
|
0
|
|
≥ 40 to < 60
|
2 (3.8)
|
0
|
1 (50.0)
|
1 (50.0)
|
0
|
0
|
|
Missing
|
1 (1.9)
|
1 (100.0)
|
0
|
0
|
0
|
0
|
|
Total
|
53 (100.0)
|
46 (86.8)
|
3 (5.7)
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2 (3.8)
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2 (3.8)
|
0
|
|
Urinary protein/urinary creatinine ratio (mg/mmol)
|
n (%)
|
≤ 113.1, n (%)
|
One value > 113.1, n (%)
|
Two values > 113.1, n (%)
|
Notable range, n (%)
|
Missing, n (%)
|
|---|
|
≤ 113.1
|
48 (90.6)
|
39 (81.3)
|
5 (10.4)
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3 (6.3)
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1 (2.1)
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0
|
|
> 113.1
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1 (1.9)
|
1 (100.0)
|
0
|
0
|
0
|
0
|
|
Missing
|
4 (7.5)
|
3 (75.0)
|
0
|
0
|
0
|
1 (25.0)
|
|
Total
|
53 (100.0)
|
43 (81.1)
|
5 (9.4)
|
3 (5.7)
|
1 (1.9)
|
1 (1.9)
|
- ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal