Question

During the course of administration of an investigational drug, the following events occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization; On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of these subject’s events meets the FDA definition of "serious" and "unexpected" and would require the sponsor to file an IND Safety Report with the FDA?

Answer 1

The stroke that need hospitalization

Step-by-step explanation:

Nausea, vomiting, headache, dizziness, all of them could consider as secondary effects of the drug, if they are annoying effects, they are not serious. But the stroke is a signal that this drug has the possibility to promote health consequences and could be end in a dead of a person, that is the reason why is necessary the safety report.