c) Is not necessarily causally related to drug Correct Answer: An adverse event is defined as one which
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to drug
d) Is life
...
c) Is not necessarily causally related to drug Correct Answer: An adverse event is defined as one which
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to drug
d) Is life threatening
d) a and b Correct Answer: An adverse event is one which
a) Is an unfavorable and unintended sign, symptom or disease
b) Is one that is temporally associated with drug regardless of whether it is related or not
c) a only
d) a and b
a) An adverse event Correct Answer: A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as
a) An adverse event
b) An adverse drug reaction
c) An unexpected adverse drug reaction
d) A serious adverse event
b) A causal relationship between drug and adverse event is a reasonable possibility
c) The relationship of the event to drug cannot be ruled out Correct Answer: A response to a medical product means (check all options that apply)
a) A causal relationship between drug and adverse event is established
b) A causal relationship between drug and adverse event is a reasonable possibility
c) The relationship of the event to drug cannot be ruled out
d) An event that requires active medical intervention
b) A noxious and unintended response to a drug Correct Answer: An adverse drug reaction is one which
a) Results in death or hospitalization
b) A noxious and unintended response to a drug
c) Occurs frequently and with greater severity than usual
d) Likely occurs at normal doses of the drug
d) a and b Correct Answer: For a drug that is in a Phase IV trial and adverse drug reaction is one which
a) Is noxious and unintended
b) Occurs at normal doses used for prophylaxis
c) a only
d) a and b
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