Table 1
Overview of Reported Potential Liver Safety Findings

−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
                                                                                                                                                       
                                                                                                    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=884)           (N=906)           (N=917)           (N=1790)            (N=1801)            (N=1823)     
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Number of Subjects with Liver                                                                                                                          
Safety Findings(a)                                                                                                                                     
Any Potential Liver Safety Findings     452/884 (51.1%)   427/906 (47.1%)   435/917 (47.4%)   −4.0 (−8.6 − 0.6)   −3.7 (−8.3 − 0.9)   0.3 (−4.3 − 4.9) 
   Findings Related to Adverse          279/884 (31.6%)   261/906 (28.8%)   288/917 (31.4%)   −2.8 (−7.0 − 1.5)   −0.2 (−4.4 − 4.1)   2.6 (−1.6 − 6.8) 
   Events                                                                                                                                              
   Findings Related to                  271/884 (30.7%)   264/906 (29.1%)   261/917 (28.5%)   −1.5 (−5.8 − 2.7)   −2.2 (−6.4 − 2.0)   −0.7 (−4.8 − 3.5)
   Biochemical Tests                                                                                                                                   
   Findings Related to Both              49/884 (5.5%)     49/906 (5.4%)     57/917 (6.2%)    −0.1 (−2.2 − 2.0)   0.7 (−1.5 − 2.8)    0.8 (−1.3 − 3.0) 
   Adverse Events and Biochemical                                                                                                                      
   Tests                                                                                                                                               
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
PL=Placebo, T1=Treatment 1, T2=Treatment 2
Note (a): A potential liver safety finding is defined as meeting any of the laboratory thresholds.
N = number of applicable subjects in treatment arm; n = actual applicable observed number with values.