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Table 1 Components and Definitions of the Primary Endpoint

From: Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension

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
  1. From New England Journal of Medicine. Galiè N, Barberà JA, Frost AE, Ghofrani HA, Hoeper MM, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Grünig E, Oudiz RJ, Vonk-Noordegraaf A, White RJ, Blair C, Gillies H, Miller KL, Harris JH, Langley J, Rubin LJ; AMBITION Investigators. Initial use of ambrisentan plus tadalafil in pulmonary arterial hypertension. Volume 373, Pages 834–844. Copyright© (2015) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society
  2. 6MWD 6-min walk distance, FC Functional class, PAH Pulmonary arterial hypertension, WHO World Health Organization