Question

A double-blinded trial for a new indication is conducted under an ind comparing 2 marketed drugs, at twice the approved prescribed doses. on day 2, subject 603 had difficulty breathing, although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. on day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications.these episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. the investigator would submit an sae report for:

Answer 1

Answer:

Here are the missing options in the question;

A.     Neither of the subjects

B.     Subject 603 only

C.    Subject 20 only

D.    Both of the subjects

The best answer choice is;

D. Both of the subjects

Explanation:

The researcher will present an SAE report for both subjects, since both must know the results for having been part of the trial, and have the information of the study and the symptoms in case these are necessary for the future.