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.
Study Type
OBSERVATIONAL
Enrollment
2,686
10 mg tablets
To estimate incidence rates for specified outcomes.
Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death.
Time frame: 1 year
To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.
Time frame: 1 year
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Investigator Site
Mobile, Alabama, United States
Investigator Site
Phoenix, Arizona, United States
Investigator Site
Phoenix, Arizona, United States
Investigator Site
Phoenix, Arizona, United States
Investigator Site
Fullerton, California, United States
Investigator Site
La Jolla, California, United States
Investigator Site
Loma Linda, California, United States
Investigator Site
Los Angeles, California, United States
Investigator Site
Los Angeles, California, United States
Investigator Site
Los Angeles, California, United States
...and 136 more locations