US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Description
Brief Summary
Prospective observational drug registry developed to characterize the safety profile
(including primarily potential serious hepatic risks) and to describe clinical
characteristics and outcomes of patients newly treated with Opsumit in the post-marketing
setting.
Phase
N/AInclusion and Exclusion Criteria
- Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit. Signed ICF
- Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment. Patients enrolled in any ongoing clinical trials
Sites
-
Ohio
- Investigator Site, Cincinnati, Ohio, 45219