Survey Instructions

Thank you for taking the time to complete this survey. Your input will help us to better harmonise industry practices. This survey will close on the 18th February 2022.
Please review each patient’s event scenario and indicate whether you think the patient has a TEAE for an intervention period summary table. A TE definition will not be provided since we will use the survey results to inform our TE definition for this study design.
Consider the following while completing the survey:  
Study Design:
  • This is a basic, two-period, two-treatment study.
  • Screening period
    • Patients undergo typical study screening assessments, and receive no study treatment.
  • Intervention period
    • Patients receive a single study treatment (either active drug or control).
    • Patients take their study treatment throughout the entire period as planned per the protocol, and there are no dosing modifications during this period.
    • Patients complete the study once this period is over, and there is no safety follow-up period afterwards.
 Adverse Events:
  • Each scenario represents the reported adverse event(s) for a single patient, with colour coding signifying the event severity.
  • The onset, recurrence and severity of the events can vary over time however, changes in drug relatedness or regulatory seriousness (e.g., from non-serious to serious and vice versa) are out of scope.
  • Everything is known about the events (e.g., each event has a start and stop date and severity is always known across time).
  • Each event is the same medical concept and it occurs continuously from start to stop.
  • Please do not consider how you currently collect AE data at your organisation; just focus on whether you think the patient has a TEAE.