Trial · NCT01931839
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 | Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 105 (Study 105) | Safety Set (study 105) included all participants in Treatment Cohort Part A who were exposed to any amount of study drug. | participants | NUMBER |
| PRIMARY | Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs | Day 1 up to Week 105 (Study 105) | Safety Set (study 105) included all participants in the Treatment Cohort Part B who were exposed to any amount of study drug. | participants | NUMBER |
| SECONDARY | Part A Treatment Cohort: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) At Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105) | Full Analysis Set (FAS) study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | percent predicted of FEV1 | LEAST_SQUARES_MEAN |
| SECONDARY | Part B Treatment Cohort: Absolute Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105) | FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | percent predicted of FEV1 | MEAN |
| SECONDARY | Part A Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105) | FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Part B Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105) | FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | percent change | MEAN |
| SECONDARY | Part A Treatment Cohort: Absolute Change From Baseline in Body Mass Index (BMI) at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105) | FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | Kilogram per square meter (kg/m^2) | LEAST_SQUARES_MEAN |
| SECONDARY | Part B Treatment Cohort: Absolute Change From Baseline in BMI at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105) | FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | kg/m^2 | MEAN |
| SECONDARY | Part A Treatment Cohort: Number of Pulmonary Exacerbations Events Per Patient-Year | Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period) | FAS (Study 103/104) was used for Arm 1 \& 3, \& included all participants randomized in previous studies \& dosed. FAS (Study 105) was used for Arm 2 \& 4, \& included all participants randomized in Part A Treatment Cohort \& dosed in current study 105. 'Number Analyzed'=those participants who were evaluable at specified time points for each arm. | events per patient year | NUMBER |
| SECONDARY | Part A Treatment Cohort: Absolute Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72 | Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 48, 72 (Study 105) | FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part B Treatment Cohort: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72 | Baseline (Study 102 Study), Day 15, Week 8, 16, 24, 48, 72 (Study 105) | FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Part A Treatment Cohort: Absolute Change From Baseline in BMI Z-score at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105) | FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Part A Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105) | FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | kilograms (kg) | MEAN |
| SECONDARY | Part B Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 | Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105) | FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively. | kg | MEAN |
| SECONDARY | Part A Treatment Cohort: Time-to-First Pulmonary Exacerbation | Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period) | FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105. | days | MEDIAN |
| SECONDARY | Part A Treatment Cohort: Percentage of Participants With at Least 1 Pulmonary Exacerbation | Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period) | FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105. | percentage of participants | NUMBER |
| SECONDARY | Part A Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline | Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60, 72, 84, 96 (Study 105) | FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105. | percentage of participants | NUMBER |
| SECONDARY | Part B Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline | Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105) | FAS (Study 102) was used for Arm 6 and 7, and included all participants randomized in the cohort 4 of study 102 and dosed. | percentage of participants | NUMBER |
| SECONDARY | Part A Observation Cohort: Number of Participants With Serious Adverse Events (SAEs) | up to 2 years | Safety Set (study 105) included all participants who were enrolled in Part A Observation Cohort. | participants | NUMBER |
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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