Post-authorisation Safety Study (PASS): Retrospective Medical Chart Review of Patients with PAH Newly Treated With Either Uptravi® (selexipag) or any Other PAH-specific Therapy (EXTRACT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective Medical Chart Review

Study drug and medical condition

• Medicinal product name:
  UPTRAVI
• Medical condition to be studied:
  Pulmonary arterial hypertension

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  910

Study design details

• Main study objective:
  This retrospective medical chart review study aims to further characterise the safety profile of Uptravi when used in clinical practice, and to describe clinical characteristics and outcomes of patients newly treated with Uptravi or newly treated with any other PAH-specific therapy who were never treated with Uptravi in the international post-marketing setting.
• Outcomes:
  Primary outcome: MACE and all-cause death; Secondary outcomes: important identified or potential risks of Uptravi
• Data analysis plan:
  a) Summary statistics of demographics, disease characteristics and clinical course in Uptravi exposed patients and patients initiating other PAH-specific therapies. b) Occurrence and incidence rate during Uptravi exposure period of all-cause death and the important identified and potential risks of Uptravi, including MACE, in the Uptravi exposed patients. c) Occurrence and incidence rates of MACE and all-cause death in the Uptravi cohort and the Other PAH-specific cohort.