Article
Clinical Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in People with Cystic Fibrosis: A Clinical Trial.
American journal of respiratory and critical care medicine - 1 Mar 2022
Nichols David P, Paynter Alex C, Heltshe Sonya L, Donaldson Scott H, Frederick Carla A, Freedman Steven D, Gelfond Daniel, Hoffman Lucas R, Kelly Andrea, Narkewicz Michael R, Pittman Jessica E, Ratjen Felix, Rosenfeld Margaret, Sagel Scott D, Schwarzenberg Sarah Jane, Singh Pradeep K, Solomon George M, Stalvey Michael S, Clancy John P, Kirby Shannon, Van Dalfsen Jill M, Kloster Margaret H, Rowe Steven M
Abstract excerpt
Rationale: The cystic fibrosis (CF) modulator drug, elexacaftor/tezacaftor/ivacaftor (ETI), proved highly effective in controlled clinical trials for individuals with at least one F508del allele, which occurs in at least 85% of people with CF. Objectives: PROMISE is a postapproval study to understand the broad effects of ETI through 30 months' clinical use in a more diverse U.S. patient population with planned...
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