Table 1 Components and Definitions of the Primary Endpoint
Component | Definition |
|---|---|
Death (all-cause) | Certificate of death |
Hospitalization for worsening PAH | Adjudicated and defined as any hospitalization for worsening PAH, lung or heart/lung transplant, atrial septostomy; participants who initiated parenteral prostanoid therapy were included in this group |
Disease progression | Adjudicated and defined as a (decrease of > 15% from baseline in 6MWD combined with WHO FC III or IV symptoms) at 2 consecutive visits separated by ≥14 days |
Unsatisfactory long-term clinical response | Adjudicated and requiring participation in the study for ≥6 months; defined as sustained WHO FC III symptoms AND any decrease from baseline in 6MWD at 2 consecutive visits separated by ≥14 days |