A Surveillance Study Is Conducted to Assess the Efficacy and Safety

question 44

Multiple Choice

A surveillance study is conducted to assess the efficacy and safety of tolvaptan, a drug currently being used in the clinical setting for treating heart failure with volume overload.  The study enrolls 8,300 patients with a variety of medical comorbidities who received tolvaptan once daily in the morning for 2 weeks.  Results showed that tolvaptan demonstrated aquaretic efficacy in patients with diuretic-resistant volume overload, but that hypernatremia was a complication in a small number of patients.  Researchers recommended a lower dose of tolvaptan in those with normonatremia and hypokalemia to prevent hypernatremia.  Which of the following best describes this type of study?

• A)Preclinical study
• B)Phase I clinical trial
• C)Phase II clinical trial
• D)Phase III clinical trial
• E)Phase IV clinical trial

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Definitions:

Lost Productivity

The decrease in work output or efficiency, often due to factors like distractions, employee dissatisfaction, or poor health.

Absenteeism

The habitual non-presence of an employee at their job, which can be indicative of larger issues like dissatisfaction, illness, or personal problems.

Psychological Capital

The state of well-being of a person, marked by their belief in their own competencies, a hopeful perspective, future-oriented desires, and their ability to bounce back from adversity.

Self-Efficacy

A person's belief in their own ability to complete tasks and achieve goals.