Health, 10.06.2020 00:57 matthi4687
During the course of 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 events meet the FDA definition of serious and unexpected and would require the sponsor to file an IND safety report with the FDA?
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During the course of the following events occurred on day 7. Subject 603 had an unexpected stroke th...
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