Objective
  • To monitor a drug on how different Adverse Events have been reported for the drug with respect to time.
  • To detect significant Drug-Event combinations (Signal) based on Statistical measures like RR, PRR, ROR, Chi-Square, EBGM
  • To validate the detected Signal by using descriptive analytics on different attributes like Patient's Age, Gender, De-challenge, Re-challenge, Concomitant Medicine, Outcome, Time to Onset, Medical History and so on accompanied by an Aggregated Analytics Narrative.
Steps in using the tool
  • Input the required product to the tool.
  • View all the Adverse Events reported for the product and select the required event to select the Drug-Event combination.
  • For the selected Signal, compare the frequency of the Signal for different attributes and refer to the Aggregated Narrative for the conclusion on whether the Signal is a Valid Signal or not.