Trial · NCT01140451
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline (Week 1 [Total Study Week 48]) up to 4 Weeks Post-Treatment (Week 100 [Total Study Week 148]) or Premature Discontinuation (PD) (whichever occurred first) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. | percent of participants | NUMBER |
| PRIMARY | Number of Participants With Any Treatment-Emergent Laboratory Abnormality (TELA) | Baseline (Week 1 [Total Study Week 48]) up to 4 Weeks Post-Treatment (Week 100 [Total Study Week 148]) or PD (whichever occurred first) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in 1 Second (FEV1) at Baseline | Baseline (Week 1 [Total Study Week 48]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percentage of predicted FEV1 | MEAN |
| SECONDARY | Percentage Change From Baseline in Percent-Predicted of FEV1 at Weeks 48 and 96 | Week 48 (Total Study Week 96), End of Treatment (EOT) (Week 96 [Total Study Week 144]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percent change | MEAN |
| POST_HOC | Percent-Predicted of FEV1 in the 96-Week Completer Population at Baseline | Baseline (Week 1 [Total Study Week 48]) | Study 009/009e 96-Week Completer Population: participants who completed 48 weeks of treatment with ataluren or placebo in Study 009 and at least 48 weeks of treatment with ataluren in Study 009e. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percentage of predicted FEV1 | MEAN |
| POST_HOC | Percentage Change From Baseline in Percent-Predicted of FEV1 in the 96-Week Completer Population Over a Total of 96 Weeks of Treatment | Week 48 (Total Study Week 96) | Study 009/009e 96-Week Completer Population: participants who completed 48 weeks of treatment with ataluren or placebo in Study 009 and at least 48 weeks of treatment with ataluren in Study 009e. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percent change | MEAN |
| POST_HOC | Percent-Predicted of FEV1 in the 144-Week Completer Population at Baseline | Baseline (Week 1 [Total Study Week 48]) | Study 009/009e 144-Week Completer Population: participants who completed 48 weeks of treatment with ataluren or placebo in Study 009 and at least 96 weeks of treatment with ataluren in Study 009e. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percentage of predicted FEV1 | MEAN |
| POST_HOC | Percentage Change From Baseline in Percent-Predicted of FEV1 in the 144-Week Completer Population Over a Total of 144 Weeks of Treatment | EOT (Week 96 [Total Study Week 144]) | Study 009/009e 144-Week Completer Population: participants who completed 48 weeks of treatment with ataluren or placebo in Study 009 and at least 96 weeks of treatment with ataluren in Study 009e. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percent change | MEAN |
| SECONDARY | Percent-Predicted of Forced Vital Capacity (FVC) at Baseline | Baseline (Week 1 [Total Study Week 48]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percentage of predicted FVC | MEAN |
| SECONDARY | Percentage Change From Baseline in Percent-Predicted of FVC at Weeks 48 and 96 | Week 48 (Total Study Week 96), EOT (Week 96 [Total Study Week 144]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percent change | MEAN |
| SECONDARY | Percent-Predicted of Forced Expiratory Flow Between 25% and 75% of Expiration (FEF25-75) at Baseline | Baseline (Week 1 [Total Study Week 48]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percentage of predicted FEF25-75 | MEAN |
| SECONDARY | Percentage Change From Baseline in Percent-Predicted of FEF25-75 at Weeks 48 and 96 | Week 48 (Total Study Week 96), EOT (Week 96 [Total Study Week 144]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | percent change | MEAN |
| SECONDARY | Number of Participants With Pulmonary Exacerbations as Defined by Modified Fuch's Criteria | Baseline (Week 1 [Total Study Week 48]) up to Week 48 and EOT (Week 96) (Total Study Weeks 96 and 144) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Pulmonary Exacerbations as Defined by Modified Fuch's Criteria Over 48 Weeks | Baseline (Week 1 [Total Study Week 48]) up to Week 48 (Total Study Week 96) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. | exacerbations | MEAN |
| SECONDARY | Duration of Pulmonary Exacerbations as Defined by Modified Fuch's Criteria | Weeks 43 up to 48 and Weeks 91 up to 96 (Total Study Weeks 91 up to 96 and Weeks 139 up to 144) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | days | MEAN |
| SECONDARY | Number of Participants With Severe Pulmonary Exacerbations as Defined by Modified Fuch's Criteria | Weeks 43 up to 48 and Weeks 91 up to 96 (Total Study Weeks 91 up to 96 and Weeks 139 up to 144) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline for the Respiratory Domain Score of the Cystic Fibrosis (CF) Questionnaire-Revised (CFQ-R) at Weeks 48 and 96 | Baseline (Week 1 [Total Study Week 48]), Week 48 (Total Study Week 96), EOT (Week 96 [Total Study Week 144]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for specified categories. | units on a scale | MEAN |
| SECONDARY | Rate of Study Drug Compliance | Baseline (Week 1 [Total Study Week 48]) up to EOT (Week 96 [Total Study Week 144]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for specified categories. | percent of doses taken | MEDIAN |
| SECONDARY | Predose Concentration of Ataluren | Predose at Weeks 1, 16, 32, 48, 64, 80 and EOT (Week 96) (Total Study Weeks 48, 64, 80 96, 112, 128, and 144, respectively) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. Here, 'Number Analyzed' signifies participants evaluable for the specified week. | micrograms/milliliter | MEAN |
| SECONDARY | Number of Participants Who Required Interventions for Pulmonary Symptoms | Baseline (Week 1 [Total Study Week 48]) up to EOT (Week 96 [Total Study Week 144]) | The Study 009e As-Treated Population: participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01140451/outcomes