Trial · NCT02456103
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 19 of 19
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | At least 1 TEAE | 222 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | Mild TEAE | 28 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | Moderate TEAE | 147 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | Severe TEAE | 46 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | Life-Threatening TEAE | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | Fatal TEAE | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | Serious TEAE | 89 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | TEAE Unrelated to Study Drug | 140 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | TEAE Unlikely Related to Study Drug | 55 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | TEAE Possibly Related to Study Drug | 23 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Ataluren | TEAE Probably Related to Study Drug | 4 | Participants | |
| Number of Participants With a Clinically Meaningful Abnormal Clinical Laboratory (Serum Biochemistry, Hematology, and Urinalysis) Parameter | Ataluren | 0 | Participants | ||
| Change From Baseline in Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) as Measured by Spirometry at Week 24 | Ataluren | Baseline | 60.219 | Standard Deviation 17.6163 | percentage of predicted FEV1 |
| Change From Baseline in Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) as Measured by Spirometry at Week 24 | Ataluren | Change from Baseline at Week 24 | 0.015 | Standard Deviation 6.7180 | percentage of predicted FEV1 |
| Change From Baseline in Percent-Predicted of Forced Vital Capacity (FVC) as Measured by Spirometry at Week 24 | Ataluren | Baseline | 75.249 | Standard Deviation 15.8508 | percentage of predicted FVC |
| Change From Baseline in Percent-Predicted of Forced Vital Capacity (FVC) as Measured by Spirometry at Week 24 | Ataluren | Change from Baseline at Week 24 | 0.166 | Standard Deviation 6.5276 | percentage of predicted FVC |
| Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Expiration (FEF25-75) as Measured by Spirometry at Week 24 | Ataluren | Baseline | 38.099 | Standard Deviation 22.0980 | percentage of FEF25-75 |
| Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Expiration (FEF25-75) as Measured by Spirometry at Week 24 | Ataluren | Change from Baseline at Week 24 | 0.698 | Standard Deviation 13.1241 | percentage of FEF25-75 |
| Rate of Pulmonary Exacerbations as Defined by Modified Fuch's Criteria Over 48 Weeks | Ataluren | 1.051 | Standard Deviation 2.1654 | exacerbations |
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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