Table 2: Elevations in Liver Biochemical Tests Based on Thresholds

Table 2

Elevations in Liver Biochemical Tests Based on Thresholds



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                                                                                              Risk                  Risk                 Risk       
                                                                                           Difference            Difference           Difference    
                                       PL                T1                T2                 T1−PL                T2−PL                T2−T1       
                                     n/N (%)           n/N (%)           n/N (%)            (95% CI)              (95% CI)             (95% CI)     
                                     (N=355)           (N=318)           (N=326)             (N=673)              (N=681)              (N=644)      
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ALT
   > 3x ULN                       9/355 (2.5%)      8/318 (2.5%)      11/326 (3.4%)     −0.0 (−2.4 − 2.4)     0.8 (−1.7 − 3.4)     0.9 (−1.8 − 3.5) 
   > 5x ULN                      63/355 (17.7%)    53/318 (16.7%)    50/326 (15.3%)     −1.1 (−6.8 − 4.6)    −2.4 (−8.0 − 3.2)    −1.3 (−7.0 − 4.3) 
   > 10x ULN                     197/355 (55.5%)   183/318 (57.5%)   190/326 (58.3%)    2.1 (−5.4 − 9.6)     2.8 (−4.7 − 10.2)     0.7 (−6.9 − 8.4) 
   > 20x ULN                     70/355 (19.7%)    60/318 (18.9%)    64/326 (19.6%)     −0.9 (−6.8 − 5.1)    −0.1 (−6.1 − 5.9)     0.8 (−5.3 − 6.9) 

AST
   > 3x ULN                       12/355 (3.4%)     11/318 (3.5%)     16/326 (4.9%)     0.1 (−2.7 − 2.8)      1.5 (−1.5 − 4.5)     1.4 (−1.6 − 4.5) 
   > 5x ULN                      93/355 (26.2%)    78/318 (24.5%)    89/326 (27.3%)     −1.7 (−8.2 − 4.9)     1.1 (−5.6 − 7.8)     2.8 (−4.0 − 9.5) 
   > 10x ULN                     236/355 (66.5%)    210/318 (66%)    208/326 (63.8%)    −0.4 (−7.6 − 6.7)    −2.7 (−9.8 − 4.5)    −2.2 (−9.6 − 5.1) 
   > 20x ULN                      10/355 (2.8%)     15/318 (4.7%)     9/326 (2.8%)      1.9 (−1.0 − 4.8)     −0.1 (−2.5 − 2.4)    −2.0 (−4.9 − 1.0) 

Total Bilirubin
   > 2x ULN                       117/355 (33%)    81/318 (25.5%)    92/326 (28.2%)    −7.5 (−14.3 − −0.6)   −4.7 (−11.6 − 2.2)    2.7 (−4.1 − 9.6) 
   > 5x ULN                      150/355 (42.3%)   154/318 (48.4%)   141/326 (43.3%)    6.2 (−1.3 − 13.7)     1.0 (−6.4 − 8.4)    −5.2 (−12.9 − 2.5)
   > 8x ULN                      63/355 (17.7%)    63/318 (19.8%)    71/326 (21.8%)     2.1 (−3.9 − 8.0)     4.0 (−2.0 − 10.0)     2.0 (−4.3 − 8.2) 

ALP
   > 2x ULN                      123/355 (34.6%)   120/318 (37.7%)   125/326 (38.3%)    3.1 (−4.2 − 10.4)    3.7 (−3.5 − 10.9)     0.6 (−6.9 − 8.1) 
   > 3x ULN                      63/355 (17.7%)    57/318 (17.9%)    47/326 (14.4%)     0.2 (−5.6 − 6.0)     −3.3 (−8.8 − 2.2)    −3.5 (−9.2 − 2.2) 

ALT or AST and Total Bilirubin
  ALT > 3x ULN and Total         314/355 (88.5%)   285/318 (89.6%)   293/326 (89.9%)    1.2 (−3.5 − 5.9)      1.4 (−3.2 − 6.1)     0.3 (−4.4 − 4.9) 
  Bilirubin > 2x ULN
  AST > 3x ULN and Total         326/355 (91.8%)   294/318 (92.5%)   301/326 (92.3%)    0.6 (−3.4 − 4.7)      0.5 (−3.6 − 4.6)    −0.1 (−4.2 − 4.0) 
  Bilirubin > 2x ULN
  ALT or AST > 3x ULN and        330/355 (93%)    298/318 (93.7%)   304/326 (93.3%)    0.8 (−3.0 − 4.5)      0.3 (−3.5 − 4.1)    −0.5 (−4.3 − 3.4) 
  Total Bilirubin > 2x ULN

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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.