This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.
Data will be collected via web-based data capture and paper surveys depending on patient preference. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.
Study Type
OBSERVATIONAL
Clinical Trials Registry Team
Irvine, California, United States
Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.
Correct responses to knowledge-related questions (i.e, potential of fibristal to cause liver injury, signs and symptoms of liver problems, and what to do in case of signs and symptoms of liver problems.)
Time frame: 18 - 24 months
Percentages of patients that recall recieving and using the Fibristal Patient Alert Card
Receipt and use of the Fibristal Patient Alert Card,
Time frame: 18 - 24 months
Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM
Timing and frequency of liver testing conducted by the patients's HCP
Time frame: 18 - 24 months
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