........... 60 11.8.3 Disease -Related Events or Outcomes Not Qualifying as SAEs ................................ .......... 60 11.8.4 Clinical Laboratory Abnormalities and Other Abnormal As sessments as AEs and SAEs .60 11.8.5 Reporting Adverse Events ................................ ................................ ................................ ...61 11.8.6 Prompt Reporting of SAEs ................................ ................................ ................................ ..61 12.0 STATISTICAL CONSIDERATIONS ................................ ................................ ............................ 63 12.1 General Statistical Considerations ................................ ................................