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?

There are eight major endocrine glands, each with a different function: pituitary gland: the “brain” of the endocrine system; regulates all seven of the other glands and secretes growth hormone.thyroid: regulates a person’s metabolic rate, which is the amount of energy expended daily by a person at rest.thymus: assists in the development of a person’s immune system.adrenal gland: regulates fluid and sodium balance within the body, and secretes epinephrine (“adrenaline”) when the body is under stress, producing the fight-or-flight response.ovaries (in females) and testes (in males): control the development of secondary sex characteristics.pancreatic islets: regulate blood sugar.pineal gland: regulates biorhythms and mood, and stimulates the onset of puberty.

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