........... 55 8.1.3 Disease -Related Events or Outcomes Not Qualifying as SAEs ................................ .......... 56 8.1.4 Clinical Laboratory Abnormalities and Other Abnormal Asses sments as AEs and SAEs .56 8.1.5 Reporting Adverse Events ................................ ................................ ................................ ...56 8.1.6 Prompt Reporting of SAEs ................................ ................................ ................................ ..57 8.2 Data Monitoring Committee ................................ ................................