1. Study design for ECLIPSE (VX-659 triple combination) and AURORA (VX-445 triple combination) phase 3 studies.
Study design for ECLIPSE (VX-659 triple combination) and AURORA (VX-445 triple combination) phase 3 studies. TEZ: tezacaftor; IVA: ivacaftor; FEV1: forced expiratory volume in 1 s. a) Randomised controlled studies in patients with F508del/minimal function genotypes: VX (n∼360) and VX (n∼360). b) Randomised controlled studies in patients with the F508del/F508del genotype: VX (n∼100) and VX (n∼100). c) Open-label extension studies: VX (n∼400) and VX (n∼400). All sample sizes are per study. #: the 4-week safety follow-up visit in the parent studies is required only for patients who do not proceed to the open-label extension studies.
Jennifer L. Taylor-Cousar et al. ERJ Open Res 2019;5:
©2019 by European Respiratory Society