What information does SDTM.AE (Adverse Events) contain?

• AE (Adverse Events) domain of SDTM belongs to events general observation class
• Events observation class is designed to capture planned protocol milestones such as randomization and study completion; and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history).
• AE domain captures the untoward medical occurrences in a patient or subjects that are administered a pharmaceutical product
• These 'untoward medical occurrences' that are captured in AE domain may not necessarily have a causal relationship with the treatment
• It contains variables to capture the details of the adverse event
  • Description of the event
  • Start and end date/time of the event
  • Severity and seriousness of the event
  • Variables to store the standardized text of the adverse event
  • Variables to categorize the event
  • Actions taken due to the event