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Trial · NCT02107859

Results by group37

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenAny TEAEs61Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenMild AEs4Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenModerate AEs26Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenSevere AEs30Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenLife-threatening AEs0Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenFatal AEs1Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenAEs unrelated to ataluren35Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenAEs unlikely related to ataluren12Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenAEs possible related to ataluren13Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenAEs probable related to ataluren1Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)AtalurenSerious TEAEs36Participants
Number of Participants With Clinically Significant Laboratory AbnormalitiesAtaluren0Participants
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at the End of Treatment (Week 192), as Assessed by SpirometryAtalurenBaseline56.203Standard Deviation 17.2964percentage of predicted FEV1
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at the End of Treatment (Week 192), as Assessed by SpirometryAtalurenChange at Week 192-1.214Standard Deviation 3.6384percentage of predicted FEV1
Percentage of Participants With Pulmonary Exacerbation, As Assessed by Modified Fuchs CriteriaAtaluren68.3percentage of participants
Percentage of Participants With Pulmonary Exacerbation, As Assessed by Expanded Fuchs' CriteriaAtaluren68.3percentage of participants
Percentage of Participants With Pulmonary Exacerbation, As Assessed by Classic Fuchs' CriteriaAtaluren58.3percentage of participants
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Final Visit (Week 196)AtalurenBaseline: RR duration828.17Standard Deviation 132.15miiliseconds
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Final Visit (Week 196)AtalurenChange at Week 196: RR duration-14.27Standard Deviation 115.62miiliseconds
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Final Visit (Week 196)AtalurenBaseline: PR duration145.02Standard Deviation 19.29miiliseconds

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.

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