Trial Purpose and Description
The specific objectives of the study are:
1. To describe demographic and clinical characteristics of patients newly treated with Opsumit at enrollment and during the observation period.
2. To describe pulmonary arterial hypertension (PAH) treatment patterns at enrollment and during the observation period.
3. To estimate the incidence rates during the observation period of:
a) Liver test abnormalities:
Aspartate aminotransferases (AST) or alanine aminotransferases (ALT): ≥ 3 × upper limit of normal (ULN):
AST or ALT: ≥ 3 and ≤ 5 × ULN
AST or ALT: > 5 and ≤ 8 × ULN
AST or ALT: > 8 × ULN
Total bilirubin (TBIL): ≥ 2 × ULN
Biochemical potential Hy¿s law cases: AST or ALT ≥ 3 × ULN associated with TBIL ≥ 2 × ULN
b) Occurrence of hepatic adverse events (HAEs)
c) Occurrence of hepatic adverse events of special interest (HAESI) as reviewed by the Independent Liver Safety Data Review Board (ILSDRB):
Reasonable possible role of the drug, or
More likely alternative explanation(s) identified, or
Difficult to assess.
d) Occurrence of any other adverse events (AEs)
e) Discontinuation of Opsumit and reason for stopping therapy
f) Hospitalization and death.
4. To provide a summary of ILSDRB medical evaluation of individual registry HAESI cases in perspective with the annual aggregated results from the OPUS registry.
Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.
Patients enrolled in any ongoing clinical trials
Actelion Clinical Operations, Inc.
Dates: 06/29/2015 - 10/01/2018
Last Updated: 12/04/2016
Study HIC#: 1503015421REG