Probably related adverse event

An adverse event that         

  • is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
  • follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure
  • ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure