Trial · NCT03447249
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | From Baseline at Week 4 | Analysis population included all participants in the Full Analysis Set (all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug) who completed the Week 4 Visit or were randomized at least 28 days before the data cutoff date. | percentage points | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) | From Baseline through Week 24 | Full analysis set (FAS) included all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug in the TC Treatment Period. | percentage points | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Pulmonary Exacerbations (PEx) | From Baseline through Week 24 | FAS. | pulmonary exacerbation events | NUMBER |
| SECONDARY | Absolute Change in Sweat Chloride (SwCl) | From Baseline through Week 24 | FAS. | millimole per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score | From Baseline through Week 24 | FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Body Mass Index (BMI) | From Baseline at Week 24 | FAS. | kilogram per meter square (kg/m^2) | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Sweat Chloride | From Baseline at Week 4 | FAS. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score | From Baseline at Week 4 | FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time-to-first Pulmonary Exacerbation (PEx) | From Baseline through Week 24 | FAS. | days | MEDIAN |
| SECONDARY | Absolute Change in BMI Z-score for Participants <=20 Years of Age at Baseline | From Baseline at Week 24 | FAS. Here Overall Number of Participants Analyzed signifies those participants who were \<=20 years of age at Baseline. | kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Body Weight | From Baseline at Week 24 | FAS. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks) | Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis. | participants | NUMBER |
| SECONDARY | Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA | Pre-dose on Week 4, 8, 12, and 16 | Pharmacokinetic (PK) set included all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug in the TC Treatment Period. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified time points. | nanogram per milliliter (ng/mL) | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03447249/outcomes