The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
822
Fixed-dose combination tablets for oral administration.
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline up to Week 148
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time frame: From Baseline up to Week 144
Absolute Change From Baseline in Sweat Chloride (SwCl)
Time frame: From Baseline up to Week 144
Number of Pulmonary Exacerbations (PEx)
Time frame: From Baseline up to Week 144
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