Trial · NCT01914757
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS. | Events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS. | Events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Liter | MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS | Liter | MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS | Scores on a scale | MEAN |
| SECONDARY | Change in Asthma Rescue Medication Use | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Puffs per day | MEAN |
| SECONDARY | Home Lung Function Assessments Based on PEF | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | L/min | MEAN |
| SECONDARY | Proportion of Nights With Awakening Due to Asthma | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Proportion of nights | MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS | Scores on a scale | MEAN |
| SECONDARY | Number of Patients With >=1 Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 56 | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Participants | NUMBER |
| SECONDARY | Time to First Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 56 | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Participants | NUMBER |
| SECONDARY | Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations | Immediately following the first administration of study drug through Study Week 56. | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Pharmacokinetics of Benralizumab | Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60 | PK analysis set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity of Benralizumab | Pre-treatment until end of follow-up | Safety analysis set | Participants | NUMBER |
| SECONDARY | Extent of Exposure | Immediately following the first administration of study drug through Study Week 56 | Safety analysis set | Days | MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in AQLQ(S)+12 | Immediately following the first administration of study drug through Study Week 56 | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 56 in EQ-5D-5L VAS | Immediately following the first administration of study drug through Study Week 56 | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS | Scores on a scale | MEAN |
| SECONDARY | Mean Work Productivity Loss Due to Asthma | Immediately following the first administration of study drug through Study Week 56 | Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS, who were employed | Percent of productivity loss | 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/NCT01914757/outcomes