Trial · NCT02107859
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline (Day 1) up to end of study (Week 196) | As-treated population included all participants who received at least 1 dose of ataluren. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities | Baseline (Day 1) up to end of study (Week 196) | As-treated population included all participants who received at least 1 dose of ataluren. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at the End of Treatment (Week 192), as Assessed by Spirometry | Baseline, Week 192 | ITT population included all participants who had at least 1 post-baseline efficacy assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable at specified timepoint. | percentage of predicted FEV1 | MEAN |
| SECONDARY | Percentage of Participants With Pulmonary Exacerbation, As Assessed by Modified Fuchs Criteria | Baseline up to Week 192 | ITT population included all participants who had at least 1 post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pulmonary Exacerbation, As Assessed by Expanded Fuchs' Criteria | Baseline up to Week 192 | ITT population included all participants who had at least 1 post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pulmonary Exacerbation, As Assessed by Classic Fuchs' Criteria | Baseline up to Week 192 | ITT population included all participants who had at least 1 post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Final Visit (Week 196) | Baseline, Week 196 | As-treated population included all participants who received at least 1 dose of ataluren. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable for specified categories. | miiliseconds | MEAN |
| SECONDARY | Change From Baseline in Heart Rate at Final Visit (Week 196), as Assessed by 12-Lead ECG | Baseline, Week 196 | As-treated population included all participants who received at least 1 dose of ataluren. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable for specified categories. | beats/minute | MEAN |
| SECONDARY | Change From Baseline in Vital Signs at Final Visit (Week 196) | Baseline, Week 196 | As-treated population included all participants who received at least 1 dose of ataluren. Here, 'Number analyzed' signifies participants evaluable for specified categories. | millimeters of mercury (mmHg) | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at the End of Treatment (Week 192), as Assessed by Spirometry | Baseline, Week 192 | ITT population included all participants who had at least 1 post-baseline efficacy assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable at specified timepoint. | percentage of predicted FVC | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Percent Predicted Forced Expiratory Flow Between 25% and 75% of Expiration (FEF25-75) at the End of Treatment (Week 192), as Assessed by Spirometry | Baseline, Week 192 | Due to change in planned analysis FEV25-75 was not calculated and summarized. |
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/NCT02107859/outcomes