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The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab 30 mg q.4 weeks | Experimental | Benralizumab administered subcutaneously every 4 weeks |
|
| Benralizumab 30 mg q.8 weeks | Experimental | Benralizumab administered subcutaneously every 8 weeks |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Biological | Benralizumab subcutaneously on study week 0 until study week 44 inclusive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF | Immediately following the first administration of study drug through Study Week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF | Immediately following the first administration of study drug through Study Week 48. |
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Inclusion Criteria:
Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.
Exclusion criteria:
Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
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| Name | Affiliation | Role |
|---|---|---|
| Eugene R. Bleecker, MD, Professor of Medicine | Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Foley | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35287231 | Derived | Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14. | |
| 32334141 | Derived |
| Label | URL |
|---|---|
| D3250C00017CSP3redacted | View source |
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2681 participants signed informed consent form, 2232 participants entered screening/run-in period,1205 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1205 patients randomised, 1204 patients received treatment with the study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Benralizumab 30 mg q.4 Weeks | Benralizumab administered every 4 weeks subcutaneously. |
| FG001 | Benralizumab 30 mg q.8 Weeks | Benralizumab administered every 8 weeks subcutaneously. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Biological | Placebo subcutaneously on study week 0 until study week 44 inclusive. |
|
| Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations |
The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated) |
| Immediately following the first administration of study drug through Study Week 48. |
| Number of Patients With >=1 Asthma Exacerbations | Immediately following the first administration of study drug through Study Week 48. |
| Time to First Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 48. |
| 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. |
| 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. |
| Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL | Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Immediately following the first administration of study drug through Study Week 48. |
| Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL | Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Immediately following the first administration of study drug through Study Week 48. |
| Change in Asthma Rescue Medication | Change from baseline to week 48 in number of rescue medication use (puffs/day) | Immediately following the first administration of study drug through Study Week 48. |
| Home Lung Function Assessment Based on Morning PEF | Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF] | Immediately following the first administration of study drug through Study Week 48. |
| Home Lung Function Assessment Based on Evening PEF | Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF] | Immediately following the first administration of study drug through Study Week 48. |
| Proportion of Night Awakening Due to Asthma | Change from baseline to Week 48 on proportion of night awakening due to asthma | Immediately following the first administration of study drug through Study Week 48. |
| Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Immediately following the first administration of study drug through Study Week 48. |
| Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Immediately following the first administration of study drug through Study Week 48. |
| Pharmacokinetics of Benralizumab | Mean PK concentrations at each visit | Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56 |
| Immunogenicity of Benralizumab | Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. | Pre-treatment until end of follow-up |
| Extend of Exposure | Extend of exposure is defined as duration of treatment in days | Immediately following the first administration of study drug through Study Week 48. |
| Mean Change From Baseline to Week 48 in AQLQ(S)+12 | AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful. | Immediately following the first administration of study drug through Study Week 48. |
| Mean Change From Baseline to Week 48 in EQ-5D-5L VAS | EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. | Immediately following the first administration of study drug through Study Week 48. |
| Mean Work Productivity Loss Due to Asthma | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population. | Immediately following the first administration of study drug through Study Week 48. |
| Mean Productivity Loss Due to Asthma in Classroom | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes | Immediately following the first administration of study drug through Study Week 48. |
| Number of Participants That Utilized Health Care Resources | Immediately following the first administration of study drug through Study Week 48. |
| Patient and Clinician's Responder Assessment to Treatment | CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed. | Immediately following the first administration of study drug through Study Week 48 |
| Huntsville |
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| Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22. |
| 31836949 | Derived | Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14. |
| 31626906 | Derived | Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15. |
| 30802500 | Derived | Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23. |
| 30139780 | Derived | Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct. |
| 30077185 | Derived | DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4. |
| 29409951 | Derived | Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1. |
| 27609408 | Derived | Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5. |
| FG002 | Placebo | Placebo administered subcutaneously |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benralizumab 30 mg q.4 Weeks | Benralizumab administered every 4 weeks subcutaneously. |
| BG001 | Benralizumab 30 mg q.8 Weeks | Benralizumab administered every 8 weeks subcutaneously. |
| BG002 | Placebo | Placebo administered subcutaneously |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF | Full analysis set, Baseline eosinophils >=300/uL | Posted | Least Squares Mean | 95% Confidence Interval | events/year | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF | Full analysis set, Baseline eosinophils <300/uL | Posted | Least Squares Mean | 95% Confidence Interval | events/year | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations | The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated) | Full analysis set, Baseline eosinophils >=300/uL | Posted | Least Squares Mean | 95% Confidence Interval | events/year | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Number of Patients With >=1 Asthma Exacerbations | Full analysis set, Baseline eosinophils >=300/uL | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Time to First Asthma Exacerbation | Full analysis set, Baseline eosinophils >=300/uL | Posted | Median | 95% Confidence Interval | Days | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL | Full analysis set, Baseline eosinopiles >=300/uL | Posted | Mean | Standard Deviation | Liter | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL | Full analysis set, Baseline eosinopiles <300/uL | Posted | Mean | Standard Deviation | Liter | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL | Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL | Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Full analysis set, Baseline eosinophils <300/uL | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Change in Asthma Rescue Medication | Change from baseline to week 48 in number of rescue medication use (puffs/day) | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | Puffs/day | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Home Lung Function Assessment Based on Morning PEF | Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF] | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | L/min | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Home Lung Function Assessment Based on Evening PEF | Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF] | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | L/min | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Proportion of Night Awakening Due to Asthma | Change from baseline to Week 48 on proportion of night awakening due to asthma | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | Proportion of nights | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Full analysis set, Baseline eosinophils <300/uL | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Pharmacokinetics of Benralizumab | Mean PK concentrations at each visit | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56 |
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| Secondary | Immunogenicity of Benralizumab | Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. | 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. | Posted | Number | Participants | Pre-treatment until end of follow-up |
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| Secondary | Extend of Exposure | Extend of exposure is defined as duration of treatment in days | 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. | Posted | Mean | Standard Deviation | Days | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in AQLQ(S)+12 | AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful. | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Change From Baseline to Week 48 in EQ-5D-5L VAS | EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. | Full analysis set, Baseline eosinophils >=300/uL | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Work Productivity Loss Due to Asthma | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population. | Full analysis set, Baseline eosinophils >=300/uL for patients who employed | Posted | Mean | Standard Deviation | Percent of productivity loss | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Mean Productivity Loss Due to Asthma in Classroom | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes | Full analysis set, Baseline eosinophils >=300/uL who attending classes | Posted | Mean | Standard Deviation | Percent of productivity loss | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Number of Participants That Utilized Health Care Resources | Full analysis set, Baseline eosinophils >=300=/uL | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 48. |
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| Secondary | Patient and Clinician's Responder Assessment to Treatment | CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed. | Full analysis set, Baseline eosinophils >=300/uL | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 48 |
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Not provided
There were 400 patients randomized to Benra q.4, and 398 patients randomized to Benra q.8. One patient in Benra q.4 was never treated. In addition, 4 patients who were randomized to q.8 group, but were treated with q.4 schedule. So 403 patients were treated with q.4 regimen, and 394 patients were treated with q.8 regimen.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benralizumab 30 mg q.4 Weeks | Benralizumab administered every 4 weeks subcutaneously. | 51 | 403 | 214 | 403 | ||
| EG001 | Benralizumab 30 mg q.8 Weeks | Benralizumab administered every 8 weeks subcutaneously. | 54 | 394 | 199 | 394 | ||
| EG002 | Placebo | Placebo administered subcutaneously | 58 | 407 | 219 | 407 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Allergic granulomatous angiitis | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Bullous impetigo | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Parotitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pneumonia pneumococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Urinary tract infection enterococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Vestibular neuronitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Adenolymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Aphonia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Cerebral venous thrombosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Sinus polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Goldman , Medical Science Director | AstraZeneca | +1 301 398 0323 | Mitchell.Goldman@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571386 | benralizumab |
Not provided
Not provided
Not provided
| Male |
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Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids |
| <0.001 |
| Rate ratio |
| 0.49 |
| 2-Sided |
| 95 |
| 0.37 |
| 0.64 |
| Superiority or Other |
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Placebo administered subcutaneously |
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Placebo administered subcutaneously |
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