................................ ......65 15.1. Adverse and Serious Adverse Events ................................ ............................. 65 Adverse Event (AE) ................................ ................................ ............ 65 Serious Adverse Event (SAE) ................................ ............................ 65 Disease -Related Events or Outcomes not Qualifying as SAEs .......... 66 Clinical Laboratory Abnormalities and Other Abnormal Assessments as AEs and SAEs ................................ ...........................