30 closest matches · ranked by relevance
Cystic Fibrosis
Primary: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) — 12; 29; 15; 14 participants
Cystic Fibrosis
Primary: Safety and Tolerability Based on Adverse Events (AEs) — 17; 16; 15; 16 participants
Cystic Fibrosis
Primary: Safety as Determined by Adverse Events (AEs) — 30; 8; 7; 15 participants
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1second (ppFEV1) — 0.0; 0.2 percentage points — p=< 0.0001
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.4; 10.4 percentage points — p=<0.0001
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 — -0.15; 2.46; 2.85 percent predicted of FEV1 — p=0.0004
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 — -0.44; 3.59; 2.16 percent predicted of FEV1 — p=<0.0001
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; 10.2 percentage points — p=< 0.0001
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — -1.0; 13.0 percentage points — p=<0.0001
Cystic Fibrosis
Primary: Safety as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 56; 15 participants
Cystic Fibrosis
Primary: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 — -3.5; -6.6 percent change…
Cystic Fibrosis
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs — 65; 66; 32; 28 Participants
Cystic Fibrosis
Primary: Safety and Tolerability — 11; 4; 6; 4 participants
Cystic Fibrosis
Primary: PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 5; 15; 13 Participants
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — -0.2; 13.6 percentage points — p=<0.0001
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; 0.5 percentage points — p=< 0.0001
Cystic Fibrosis
Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 — -0.1; 1 Percentage of predicted FEV1 — p== 0.1176
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for ELX/TEZ/IVA Group — 3.7 percentage points
Cystic Fibrosis
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 9; 10; 15; 17 participants
Cystic Fibrosis
Primary: Incidence of Subjects Experiencing Treatment Emergent Adverse Events From Baseline Through End of Study — 3; 2; 7; 4 Participants
Cystic Fibrosis
Primary: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 — 0.08; -1.01 Ratio — p=< 0.0001
Cystic Fibrosis
Primary: Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score — 1.2; 17.1 units on a scale — p=< 0.0001
Cystic Fibrosis
Primary: Absolute Change From Baseline in Mucociliary Clearance (MCC) at Day 28 — -0.5; -0.9 percentage of whole-lung clearance — p=0.7151
Cystic Fibrosis
Primary: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 — -0.6; 3.4 Percentage of predicted FEV1…
Cystic Fibrosis
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 9; 9; 9; 15 participants
Cystic Fibrosis
Primary: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; -2.2; 2.0; 4.5 percent predicted FEV1 (%)
Cystic Fibrosis
Primary: Intra-subject Change From Baseline of CFTR-mediated Total Chloride Transport as Measured by Nasal Potential Difference (NPD). — 1.86; -0.75; -1.11; 1.66 mV
Cystic Fibrosis
Primary: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 — -0.3; 4.4; 6.5 percentage of…
Cystic Fibrosis
Primary: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 0; 3; 1; 2 Participants
Cystic Fibrosis
Primary: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 129; 31…