Serious Adverse Event (SAE) Reporting

• The FDA and ICH SAE definition was used in all studies (protocols and case report forms)

• An SAE is defined as any adverse drug experience occurring at any dose that results in any of the following outcomes:

  • Life-threatening
  • Death
  • Hospitalization/prolongation of hospitalization
  • Congenital anomaly
  • Persistent or significant disability/incapacity
  • Required intervention to prevent permanent impairment/damage

• All SAEs were reported according to the FDA and ICH definition

Safety-SAEs

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