Trial · NCT01928771
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
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 Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \<300/uL | events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With >=1 Asthma Exacerbations | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Participants | NUMBER |
| SECONDARY | Time to First Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Days | MEDIAN |
| SECONDARY | Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinopiles \>=300/uL | Liter | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinopiles \<300/uL | Liter | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \<300/uL | Scores on a scale | MEAN |
| SECONDARY | Change in Asthma Rescue Medication | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Puffs/day | MEAN |
| SECONDARY | Home Lung Function Assessment Based on Morning PEF | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | L/min | MEAN |
| SECONDARY | Home Lung Function Assessment Based on Evening PEF | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | L/min | MEAN |
| SECONDARY | Proportion of Night Awakening Due to Asthma | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Proportion of nights | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \<300/uL | Scores on a scale | MEAN |
| SECONDARY | Pharmacokinetics of Benralizumab | Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56 | PK analysis set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity of Benralizumab | Pre-treatment until end of follow-up | Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398. However, data were only available for 402 patients in q.4, and 393 patients in q.8. | Participants | NUMBER |
| SECONDARY | Extend of Exposure | Immediately following the first administration of study drug through Study Week 48. | Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398. | Days | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in AQLQ(S)+12 | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Week 48 in EQ-5D-5L VAS | Immediately following the first administration of study drug through Study Week 48. | Full analysis set, Baseline eosinophils \>=300/uL | Scores 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/NCT01928771/outcomes