Table 4
Summary of Treatment Emergent Adverse Events of Adverse Events Meeting the Liver Safety SMQ (or FMQ)
<Analysis Set>
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
                                                                                              Risk                  Risk                 Risk       
                                                                                           Difference            Difference           Difference    
                                            T1              PL              T2                T1−PL                T2−PL                T2−T1       
                                          n/N (%)         n/N (%)         n/N (%)           (95% CI)              (95% CI)             (95% CI)     
Preferred Term                            (N=356)         (N=309)         (N=334)            (N=665)              (N=643)              (N=690)      
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
Number of patients                      247 (69.4%)     196 (63.4%)     226 (67.7%)     6.0 (−1.2 − 13.1)    4.2 (−3.1 − 11.6)    −1.7 (−8.7 − 5.2) 
reporting at least one                                                                                                                              
Narrow or Broad Scope PT                                                                                                                            
Narrow Scope PTs                                                                                                                                    
   Hepatic failure, fibrosis,           44 (12.4%)      37 (12.0%)       27 (8.1%)      0.4 (−4.6 − 5.4)     −3.9 (−8.5 − 0.8)    −4.3 (−8.8 − 0.2) 
   and cirrhosis and other liver                                                                                                                    
   damage−related conditions                                                                                                                        
   Hepatitis, non−infectious            70 (19.7%)      42 (13.6%)      62 (18.6%)      6.1 (0.4 − 11.7)     5.0 (−0.7 − 10.6)    −1.1 (−7.0 − 4.8) 
   Liver neoplasms, benign              65 (18.3%)      42 (13.6%)      68 (20.4%)      4.7 (−0.9 − 10.2)     6.8 (1.0 − 12.5)     2.1 (−3.8 − 8.0) 
   (incl cysts and polyps)                                                                                                                          
   Liver neoplasms, malignant           85 (23.9%)      75 (24.3%)      103 (30.8%)     −0.4 (−6.9 − 6.1)    6.6 (−0.3 − 13.4)     7.0 (0.3 − 13.6) 
   and unspecified                                                                                                                                  
−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−
N=number of applicable subjects in treatment arm; n=actual applicable observed number with values.