Trial · NCT02139306
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 54
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 | Ataluren | -1.396 | 95% Confidence Interval -2.7735 to -0.0180 | Percentage of predicted FEV1 | |
| Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 | Placebo | -1.992 | 95% Confidence Interval -3.3271 to -0.6576 | Percentage of predicted FEV1 | |
| 48-week Rate of Pulmonary Exacerbations | Ataluren | 0.950 | Standard Deviation 1.4038 | number of exacerbations per 48 weeks | |
| 48-week Rate of Pulmonary Exacerbations | Placebo | 1.127 | Standard Deviation 2.5241 | number of exacerbations per 48 weeks | |
| Change From Baseline in the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Domain at Week 48 | Ataluren | -0.760 | 95% Confidence Interval -3.4566 to 1.9364 | units on a scale | |
| Change From Baseline in the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Domain at Week 48 | Placebo | -1.032 | 95% Confidence Interval -3.7368 to 1.6728 | units on a scale | |
| Change From Baseline in Body Mass Index (BMI) at Week 48 | Ataluren | 0.296 | 95% Confidence Interval 0.1126 to 0.4789 | kilogram per meter square (kg/m^2) | |
| Change From Baseline in Body Mass Index (BMI) at Week 48 | Placebo | 0.361 | 95% Confidence Interval 0.1759 to 0.5455 | kilogram per meter square (kg/m^2) | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Ataluren | TEAEs | 133 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | TEAEs | 135 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Ataluren | SAEs | 40 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Placebo | SAEs | 46 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Ataluren | Severity: Grade 1 | 26 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Placebo | Severity: Grade 1 | 18 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Ataluren | Severity: Grade 2 | 88 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Placebo | Severity: Grade 2 | 88 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Ataluren | Severity: Grade 3 | 19 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Placebo | Severity: Grade 3 | 29 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Ataluren | Severity: Grade 4 | 0 | participants | |
| Number of Participants With TEAEs by Severity and Relationship to Study Drugs | Placebo | Severity: Grade 4 | 0 | participants |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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