Trial · NCT03447262
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to 28 Days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100) | Open label safety set (OL-SS) included all participants who received at least 1 dose of study drug in the current study 659-105. | participants | NUMBER |
| SECONDARY | Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for Participants From the Parent Study 659-102 | From Baseline at Week 72 (Study 659-105) | Open label full analysis set (OL-FAS) included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | percentage points | MEAN |
| SECONDARY | Absolute Change in ppFEV1 for Participants From the Parent Study 659-103 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | percentage points | MEAN |
| SECONDARY | Absolute Change in Sweat Chloride (SwCl) for Participants From the Parent Study 659-102 | From Baseline at Week 24 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | millimole per liter (mmol/L) | MEAN |
| SECONDARY | Absolute Change in SwCl for Participants From the Parent Study 659-103 | From Baseline at Week 24 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | mmol/L | MEAN |
| SECONDARY | Number of Pulmonary Exacerbations (PEx) for Participants From the Parent Study 659-102 | From Baseline up to Week 96 (Study 659-105) | The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-102 and/or received at least one dose of study drug during the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | PEx events | NUMBER |
| SECONDARY | Number of PEx for Participants From the Parent Study 659-103 | From Baseline up to Week 96 (Study 659-105) | The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-103 and/or received at least one dose of study drug during the current study 659-105. | PEx events | NUMBER |
| SECONDARY | Number of Participants With at Least One PEx for Participants From the Parent Study 659-102 | From Baseline up to Week 96 (Study 659-105) | The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-102 and/or received at least one dose of study drug during the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | participants | NUMBER |
| SECONDARY | Number of Participants With at Least One PEx for Participants From the Parent Study 659-103 | From Baseline up to Week 96 (Study 659-105) | The cumulative TC efficacy set for PEx analysis included all participants who were randomized to VX-659/TEZ/IVA arm and received at least one dose of study drug during the parent study 659-103 and/or received at least one dose of study drug during the current study 659-105. | participants | NUMBER |
| SECONDARY | Absolute Change in Body Mass Index (BMI) for Participants From the Parent Study 659-102 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | kilogram per meter square (kg/m^2) | MEAN |
| SECONDARY | Absolute Change in BMI for Participants From the Parent Study 659-103 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | kg/m^2 | MEAN |
| SECONDARY | Absolute Change in BMI Z-score for Participants From the Parent Study 659-102 (Participants <=20 Years Old at Parent Study Baseline) | From Baseline at Week 60 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-102 who were \<=20 years old at parent study baseline and received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | z-score | MEAN |
| SECONDARY | Absolute Change in BMI Z-score for Participants From The Parent Study 659-103 (Participants <=20 Years Old at Parent Study Baseline) | From Baseline at Week 60 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-103 who were \<=20 years old at parent study baseline and received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | z-score | MEAN |
| SECONDARY | Absolute Change in Body Weight for Participants From the Parent Study 659-102 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | kg | MEAN |
| SECONDARY | Absolute Change in Body Weight for Participants From the Parent Study 659-103 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | kg | MEAN |
| SECONDARY | Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for Participants From the Parent Study 659-102 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-102 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | units on a scale | MEAN |
| SECONDARY | Absolute Change in CFQ-R Respiratory Domain Score for Participants From the Parent Study 659-103 | From Baseline at Week 72 (Study 659-105) | OL-FAS included all rolled over participants from the parent study 659-103 who received at least 1 dose of study drug in the current study 659-105. Here, number analyzed signifies participants who were evaluable for the specified category. | units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03447262/outcomes