Trial · NCT01841762
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 28
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT) | Macitentan | Item number in symptoms part of baseline | 16 | Items | |
| Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT) | Macitentan | Item number in symptoms part at Week 16 | 11 | Items | |
| Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT) | Macitentan | Item number in impacts part at baseline | 25 | Items | |
| Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT) | Macitentan | Item number in impacts part at Week 16 | 11 | Items | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability. | Macitentan | ICCs of Cardiopulmonary Symptoms domain | 0.94 | Intra-class correlation coefficient | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability. | Macitentan | ICCs of Cardiovascular Symptoms domain | 0.93 | Intra-class correlation coefficient | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability. | Macitentan | ICCs of Physical Impacts domain | 0.91 | Intra-class correlation coefficient | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability. | Macitentan | ICCs of Cognitive/Emotional Impacts domain | 0.84 | Intra-class correlation coefficient | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability. | Macitentan | Cronbach's Alpha for Cardiopulmonary Symptoms | 0.81 | Ratio of variance | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability. | Macitentan | Cronbach's Alpha for Cardiovascular Symptoms | 0.88 | Ratio of variance | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability. | Macitentan | Cronbach's Alpha for Physical Impacts Domain | 0.92 | Ratio of variance | |
| Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability. | Macitentan | Cronbach's Alpha for Cognitive/Emotional Impacts | 0.87 | Ratio of variance | |
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits) | Macitentan | Participants with AEs | 228 | Participants | |
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits) | Macitentan | Participants with severe intensity AEs | 36 | Participants | |
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits) | Macitentan | Participants with SAEs | 49 | Participants | |
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits) | Macitentan | Participants prematurely discontinued study drug | 17 | Participants | |
| Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16. | Macitentan | Cardiopulmonary Symptoms domain score at baseline | 1.0 | Inter-Quartile Range 0.5 to 1.3 | Score on a scale |
| Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16. | Macitentan | Cardiopulmonary Symptoms domain score at Week 8 | 0.8 | Inter-Quartile Range 0.4 to 1.2 | Score on a scale |
| Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16. | Macitentan | Cardiopulmonary Symptoms domain score at Week 16 | 0.7 | Inter-Quartile Range 0.4 to 1.2 | Score on a scale |
| Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16. | Macitentan | Cardiovascular Symptoms domain score at baseline | 0.4 | Inter-Quartile Range 0.1 to 0.7 | Score on a scale |
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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