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 Serious Adverse Events (SAEs)

If a patient has a Serious Adverse Event whilst taking part in the study this needs to be reported to SEWTU within 24 hours, by completing the POETIC SAE form

The definition of a serious adverse event can be found in the Protocol and is as follows:

Any adverse event that:

  • Results in death
  • Is life-threatening
  • Required hospitalisation or prolongation of existing hospitalisation
  • Results in persistent or significant disability or incapacity
  • Consists of a congenital anomaly or birth defect
  • Other medically important condition