Trial · NCT02871778
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 | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Part A: From first dose of study drug up 84 days | Part A safety set included all participants who received at least 1 dose of study drug in Part A. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Part B: Day 85 up to 28 days after last dose of study drug (56 days) | Part B safety set included all participants who received at least 1 dose of ivacaftor in Part B. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 29 | Part A: Study Baseline, Day 29 of each treatment period | Part A FAS included all randomized participants who received at least 1 dose of study drug in Part A and had a confirmed diagnosis of PCD. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure. | Percentage of predicted FEV1 | LEAST_SQUARES_MEAN |
| PRIMARY | Part B: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 29 | Study Baseline, Day 29 of Part B | Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure. | Percentage of predicted FEV1 | LEAST_SQUARES_MEAN |
| PRIMARY | Part B: Absolute Change From Part B Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 29 | Part B Baseline, Day 29 of Part B | Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure. | Percentage of predicted FEV1 | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Change From Study Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29 | Study Baseline, Day 29 of Part A | Part A FAS included all randomized participants who received at least 1 dose of study drug in Part A and had a confirmed diagnosis of PCD. Here, overall number of participants analyzed signifies adult participants evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Study Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29 | Study Baseline, Day 29 of Part B | Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, overall number of participants analyzed signifies adult participants evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Part B Baseline in Quality of Life-Primary Ciliary Dyskinesia (QOL-PCD) (Adult Version) Lower Respiratory Symptoms Domain Score at Day 29 | Part B Baseline, Day 29 of Part B | Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, overall number of participants analyzed signifies adult participants evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Study Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score for Participants Aged Greater Than or Equals to (>=) 16 Years at Day 29 | Study Baseline, Day 29 of Part A | Part A FAS included all randomized participants who received at least 1 dose of study drug in Part A and had a confirmed diagnosis of PCD. Here, overall number of participants analyzed signifies participants \>=16 years of age evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Study Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score for Participants Aged >=16 Years at Day 29 | Study Baseline, Day 29 of Part B | Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, overall number of participants analyzed signifies participants \>=16 years of age evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Part B Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score for Participants Aged >=16 Years at Day 29 | Part B Baseline, Day 29 of Part B | Part B FAS included all participants who had a confirmed diagnosis of PCD and received at least 1 dose of ivacaftor in Part B. Here, overall number of participants analyzed signifies participants \>=16 years of age evaluable for this outcome measure. | score on a scale | 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.
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GET https://conductscience.org/api/trials/v1/NCT02871778/outcomes