Table 3
Shifts in Liver Biochemical Tests Based on Thresholds
<Analysis Set>
Maximum Post−Baseline Result
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Maximum Baseline Value < 3x ULN >= 3 to < 5x ULN >= 5 to < 10x ULN >= 10 to < 20x ULN >= 20x ULN Missing
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
ALT
PL (N=355)
< 3x ULN 0 0 0 10 (0.7%) 6 (1.4%) 0
>= 3 to < 5x ULN 0 0 2 (0.2%) 7 (0.5%) 0 0
>= 5 to < 10x ULN 1 (0.1%) 0 3 (0.3%) 40 (2.6%) 19 (4.3%) 0
>= 10 to < 20x ULN 0 0 11 (1.2%) 116 (7.6%) 70 (15.9%) 0
>= 20x ULN 0 1 (0.2%) 4 (0.5%) 40 (2.6%) 25 (5.7%) 0
Missing 0 0 0 0 0 0
T1 (N=318)
< 3x ULN 0 1 (0.2%) 1 (0.1%) 5 (0.3%) 7 (1.6%) 0
>= 3 to < 5x ULN 0 0 0 5 (0.3%) 3 (0.7%) 0
>= 5 to < 10x ULN 0 0 3 (0.3%) 32 (2.1%) 18 (4.1%) 0
>= 10 to < 20x ULN 0 0 6 (0.7%) 98 (6.4%) 79 (18.0%) 0
>= 20x ULN 0 1 (0.2%) 3 (0.3%) 36 (2.4%) 20 (4.5%) 0
Missing 0 0 0 0 0 0
T2 (N=326)
< 3x ULN 0 0 0 9 (0.6%) 2 (0.5%) 0
>= 3 to < 5x ULN 0 0 0 10 (0.7%) 1 (0.2%) 0
>= 5 to < 10x ULN 0 0 3 (0.3%) 30 (2.0%) 17 (3.9%) 0
>= 10 to < 20x ULN 0 1 (0.2%) 10 (1.1%) 118 (7.7%) 61 (13.9%) 0
>= 20x ULN 0 0 2 (0.2%) 36 (2.4%) 26 (5.9%) 0
Missing 0 0 0 0 0 0
AST
PL (N=355)
< 3x ULN 0 0 3 (0.3%) 6 (0.4%) 0 0
>= 3 to < 5x ULN 0 0 0 8 (0.5%) 0 0
>= 5 to < 10x ULN 0 0 9 (1.0%) 65 (4.3%) 10 (2.3%) 0
>= 10 to < 20x ULN 0 0 25 (2.8%) 193 (12.7%) 19 (4.3%) 0
>= 20x ULN 0 0 2 (0.2%) 13 (0.9%) 2 (0.5%) 0
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
PL=Placebo, T1=Treatment 1, T2=Treatment 2, ALT=alanine aminotransferase, AST=aspartate aminotransferase, ALP=alkaline phosphatase;
N=number of applicable subjects in treatment arm; n=actual applicable observed number with values.
Table 3
Shifts in Liver Biochemical Tests Based on Thresholds
<Analysis Set>
Maximum Post−Baseline Result
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Maximum Baseline Value < 3x ULN >= 3 to < 5x ULN >= 5 to < 10x ULN >= 10 to < 20x ULN >= 20x ULN Missing
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
AST
PL (N=355)
Missing 0 0 0 0 0 0
T1 (N=318)
< 3x ULN 0 0 0 5 (0.3%) 1 (0.2%) 0
>= 3 to < 5x ULN 0 0 2 (0.2%) 9 (0.6%) 0 0
>= 5 to < 10x ULN 0 0 9 (1.0%) 60 (3.9%) 2 (0.5%) 0
>= 10 to < 20x ULN 0 0 15 (1.7%) 184 (12.1%) 19 (4.3%) 0
>= 20x ULN 0 0 1 (0.1%) 8 (0.5%) 3 (0.7%) 0
Missing 0 0 0 0 0 0
T2 (N=326)
< 3x ULN 0 0 0 7 (0.5%) 2 (0.5%) 0
>= 3 to < 5x ULN 0 0 0 10 (0.7%) 0 0
>= 5 to < 10x ULN 0 0 10 (1.1%) 62 (4.1%) 9 (2.0%) 0
>= 10 to < 20x ULN 0 1 (0.2%) 21 (2.4%) 172 (11.3%) 15 (3.4%) 0
>= 20x ULN 0 0 0 13 (0.9%) 4 (0.9%) 0
Missing 0 0 0 0 0 0
Total Bilirubin
PL (N=355)
< 3x ULN 0 6 (1.3%) 32 (3.6%) 6 (0.4%) 0 0
>= 3 to < 5x ULN 3 (0.4%) 4 (0.9%) 66 (7.5%) 11 (0.7%) 0 0
>= 5 to < 10x ULN 7 (1.0%) 30 (6.7%) 140 (15.9%) 26 (1.7%) 0 0
>= 10 to < 20x ULN 0 2 (0.4%) 20 (2.3%) 2 (0.1%) 0 0
>= 20x ULN 0 0 0 0 0 0
Missing 0 0 0 0 0 0
T1 (N=318)
< 3x ULN 1 (0.1%) 5 (1.1%) 30 (3.4%) 4 (0.3%) 0 0
>= 3 to < 5x ULN 1 (0.1%) 9 (2.0%) 54 (6.1%) 5 (0.3%) 0 0
>= 5 to < 10x ULN 3 (0.4%) 25 (5.6%) 142 (16.1%) 23 (1.5%) 0 0
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
PL=Placebo, T1=Treatment 1, T2=Treatment 2, ALT=alanine aminotransferase, AST=aspartate aminotransferase, ALP=alkaline phosphatase;
N=number of applicable subjects in treatment arm; n=actual applicable observed number with values.
Table 3
Shifts in Liver Biochemical Tests Based on Thresholds
<Analysis Set>
Maximum Post−Baseline Result
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Maximum Baseline Value < 3x ULN >= 3 to < 5x ULN >= 5 to < 10x ULN >= 10 to < 20x ULN >= 20x ULN Missing
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Total Bilirubin
T1 (N=318)
>= 10 to < 20x ULN 0 2 (0.4%) 13 (1.5%) 1 (0.1%) 0 0
>= 20x ULN 0 0 0 0 0 0
Missing 0 0 0 0 0 0
T2 (N=326)
< 3x ULN 0 6 (1.3%) 28 (3.2%) 8 (0.5%) 0 0
>= 3 to < 5x ULN 2 (0.3%) 5 (1.1%) 64 (7.2%) 8 (0.5%) 0 0
>= 5 to < 10x ULN 2 (0.3%) 30 (6.7%) 138 (15.6%) 23 (1.5%) 0 0
>= 10 to < 20x ULN 0 3 (0.7%) 8 (0.9%) 1 (0.1%) 0 0
>= 20x ULN 0 0 0 0 0 0
Missing 0 0 0 0 0 0
ALP
PL (N=355)
< 3x ULN 187 (26.6%) 99 (22.2%) 2 (0.2%) 0 0 0
>= 3 to < 5x ULN 45 (6.4%) 22 (4.9%) 0 0 0 0
>= 5 to < 10x ULN 0 0 0 0 0 0
>= 10 to < 20x ULN 0 0 0 0 0 0
>= 20x ULN 0 0 0 0 0 0
Missing 0 0 0 0 0 0
T1 (N=318)
< 3x ULN 178 (25.3%) 87 (19.6%) 0 0 0 0
>= 3 to < 5x ULN 33 (4.7%) 19 (4.3%) 0 0 0 0
>= 5 to < 10x ULN 1 (0.1%) 0 0 0 0 0
>= 10 to < 20x ULN 0 0 0 0 0 0
>= 20x ULN 0 0 0 0 0 0
Missing 0 0 0 0 0 0
T2 (N=326)
< 3x ULN 193 (27.5%) 71 (16.0%) 1 (0.1%) 0 0 0
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
PL=Placebo, T1=Treatment 1, T2=Treatment 2, ALT=alanine aminotransferase, AST=aspartate aminotransferase, ALP=alkaline phosphatase;
N=number of applicable subjects in treatment arm; n=actual applicable observed number with values.
Table 3
Shifts in Liver Biochemical Tests Based on Thresholds
<Analysis Set>
Maximum Post−Baseline Result
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Maximum Baseline Value < 3x ULN >= 3 to < 5x ULN >= 5 to < 10x ULN >= 10 to < 20x ULN >= 20x ULN Missing
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
ALP
T2 (N=326)
>= 3 to < 5x ULN 46 (6.5%) 15 (3.4%) 0 0 0 0
>= 5 to < 10x ULN 0 0 0 0 0 0
>= 10 to < 20x ULN 0 0 0 0 0 0
>= 20x ULN 0 0 0 0 0 0
Missing 0 0 0 0 0 0
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
PL=Placebo, T1=Treatment 1, T2=Treatment 2, ALT=alanine aminotransferase, AST=aspartate aminotransferase, ALP=alkaline phosphatase;
N=number of applicable subjects in treatment arm; n=actual applicable observed number with values.