Table 4 Shift tables of laboratory values based on notable/extended ranges
Baseline | Worst post-baseline value | |||||
|---|---|---|---|---|---|---|
ALT (U/L) | n (%) | ≤ ULN, n (%) | > ULN to ≤ 5 × ULN, n (%) | > 5 × ULN, n (%) | Notable range, n (%) | Extended range, n (%) |
≤ ULN | 34 (64.2) | 19 (55.9) | 14 (41.2) | 0 | 0 | 1 (2.9) |
> ULN to ≤ 5 × ULN | 19 (35.8) | 0 | 17 (89.5) | 0 | 2 (10.5) | 0 |
Total | 53 (100.0) | 19 (35.8) | 31 (58.5) | 0 | 2 (3.8) | 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) | 17 (41.5) | 0 | 0 | 1 (2.4) |
> ULN to ≤ 5 × ULN | 12 (22.6) | 0 | 12 (100.0) | 0 | 0 | 0 |
Total | 53 (100.0) | 23 (43.4) | 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 (%) |
|---|---|---|---|---|---|---|
≥ 60 | 50 (94.3) | 45 (90.0) | 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) | 2 (3.8) | 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) | 3 (6.3) | 1 (2.1) | 0 |
> 113.1 | 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) |