Trial · NCT02090959
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
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 6 weeks post-treatment (Week 150) | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Clinical Laboratory Parameters | Baseline (Day 1) up to 6 weeks post-treatment (Week 150) | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in 6MWD at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline 6MWD value at specified timepoint. | meters | MEAN |
| SECONDARY | Change From Baseline in Time to Stand From Supine Position at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | seconds | MEAN |
| SECONDARY | Change From Baseline in Time to Walk/Run 10 Meters at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | seconds | MEAN |
| SECONDARY | Change From Baseline in Time to Climb 4 Stairs at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | seconds | MEAN |
| SECONDARY | Change From Baseline in Time to Descend 4 Stairs at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | seconds | MEAN |
| SECONDARY | Change From Baseline in Physical Function Total Score as Measured by NSAA at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in PUL Total Score at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted FVC as Measured by Spirometry at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | percent predicted FVC | MEAN |
| SECONDARY | Change From Baseline in Percent Predicted FEV1 as Measured by Spirometry at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | percent predicted FEV1 | MEAN |
| SECONDARY | Change From Baseline in PEF as Measured by Spirometry at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | L/sec | MEAN |
| SECONDARY | Change From Baseline in PCF as Measured by Spirometry at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | L/sec | MEAN |
| SECONDARY | Change From Baseline in PODCI Transfers/Basic Mobility Score at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Activities of Daily Living and Disease Status at Week 144, as Assessed by a Standardized Survey Administered by Site Personnel | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Number analyzed 'signifies participants evaluable for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ataluren Plasma Concentration | Pre-dose at Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | micrograms/milliliter (μg/mL) | MEAN |
| SECONDARY | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | beats/minute | MEAN |
| SECONDARY | Change From Baseline in Body Temperature at Week 144 | Baseline, Week 144 | AT population included all participants who received at least 1 dose of ataluren treatment in this extension study. Here, 'Overall number of participants analyzed' = participants who had both baseline and post-baseline value of this parameter at specified timepoint. | degrees centigrade | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02090959/outcomes