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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1162-2422 | Other Identifier | WHO |
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The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).
Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.
At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab Arm A | Experimental | Benralizumab administered subcutaneously |
|
| Benralizumab Arm B | Experimental | Benralizumab administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Biological | Benralizumab administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Basophils. | Week 56 |
| Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Basophils. | Week 108 |
| Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Leukocytes. | Week 56 |
| Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Leukocytes. | Week 108 |
| Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Lymphocytes. | Week 56 |
| Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Lymphocytes. | Week 108 |
| Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Neutrophils. | Week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Overall Patients With Asthma Exacerbations During Study Period | Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit | From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) |
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Inclusion criteria
Exclusion criteria
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:
A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study 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 interfere with the patient's ability to complete the entire duration of the study
Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product
Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
Planned major surgical procedures during the conduct of the study
Previous participation in the present study
Concurrent enrolment in another clinical trial
AstraZeneca staff involved in the planning and/or conduct of the study
Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
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| Name | Affiliation | Role |
|---|---|---|
| William W. Busse, M.D., Professor of Medicine | Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Andalusia | Alabama | 36420 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33609624 | Derived | Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17. | |
| 30416083 |
| Label | URL |
|---|---|
| Related Info | View source |
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953 participants from SIROCCO/CALIMA receive benralizumab 30 mg at every 4 weeks during BORA. 971 participants from SIROCCO/CALIMA receive treatment at every 8 weeks during BORA. 100 participants from ZONDA receive treatment at every 4 weeks during BORA. 97 participants from study ZONDA receive treatment at every 8 weeks during BORA.
2133 patients entered BORA. 10 were excluded due to a GCP breach. Of remaining 2123 patients, 1926 entered from SIROCCO/CALIMA and 197 from ZONDA. 2 patients were not treated, and a total of 447 patients (348 SIROCCO/CALIMA and 99 ZONDA) were later enrolled into MELTEMI without completing the follow-up in BORA, so not in the main analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| FG001 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2016 | Oct 15, 2018 |
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| Benralizumab |
| Biological |
Benralizumab administered subcutaneously |
|
| Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Neutrophils. | Week 108 |
| Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Eosinophils. | Week 56 |
| Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Eosinophils. | Week 108 |
| Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry tests ALT. | Week 56 |
| Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of ALT. | Week 108 |
| Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry tests AST. | Week 56 |
| Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of AST. | Week 108 |
| Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry test Bilirubin. | Week 56 |
| Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Bilirubin. | Week 108 |
| Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit | From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose) |
| Change From Baseline in Pre-bronchodilator FEV1 (L) | Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1). | Week 56 |
| Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1). | Week 108 |
| Change From Baseline in Post-bronchodilator FEV1 (L) | Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1). | Week 56 |
| Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1). | Week 108 |
| Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses. | Week 56 |
| Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses. | Week 108 |
| Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement. | Week 56 |
| Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement. | Week 108 |
| Change of Blood Eosinophil Levels' Measurement in Overall Patients | Change from baseline to Week 56 in Blood eosinophils | Week 56 |
| Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Change from baseline to Week 108 in Blood eosinophils. | Week 108 |
| Change From Baseline in EQ-5D-5L Visual Analog Scale | The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement. | Week 56 |
| Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement. | Week 108 |
| Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage. | Week 68 |
| Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage. | Week 108 |
| Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage. | Week 56 |
| Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage. | Week 108 |
| Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Week 68 |
| Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Week 108 |
| Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma | From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose) |
| Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma | Baseline and Week 108 |
| Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Endpoint: Pharmacokinetic (PK) parameters | Week 0 and Week 56 |
| Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Endpoint: Pharmacokinetic (PK) parameters | Baseline and Week 108 |
| Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study | From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period |
| Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Assessments for the presence of ADA and nAb throughout study | From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Research Site | Scottsboro | Alabama | 35768 | United States |
| Research Site | Glendale | Arizona | 85306 | United States |
| Research Site | Phoenix | Arizona | 85012 | United States |
| Research Site | Alhambra | California | 91801 | United States |
| Research Site | Bakersfield | California | 93301 | United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Redondo Beach | California | 90277 | United States |
| Research Site | Roseville | California | 95661 | United States |
| Research Site | Sacramento | California | 95825 | United States |
| Research Site | San Jose | California | 95117 | United States |
| Research Site | Stockton | California | 95204 | United States |
| Research Site | Walnut Creek | California | 94598 | United States |
| Research Site | Westminster | California | 92683 | United States |
| Research Site | Woodland | California | 95695 | United States |
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Research Site | Denver | Colorado | 80206 | United States |
| Research Site | Wheat Ridge | Colorado | 80033 | United States |
| Research Site | New Haven | Connecticut | 06520 | United States |
| Research Site | Brandon | Florida | 33511 | United States |
| Research Site | Clearwater | Florida | 33765 | United States |
| Research Site | Cutler Bay | Florida | 33189 | United States |
| Research Site | Doral | Florida | 33172 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Hialeah | Florida | 33013 | United States |
| Research Site | Homestead | Florida | 33030 | United States |
| Research Site | Miami | Florida | 33015 | United States |
| Research Site | Miami | Florida | 33126 | United States |
| Research Site | Miami | Florida | 33134 | United States |
| Research Site | Miami | Florida | 33135 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | Ocala | Florida | 34471-4463 | United States |
| Research Site | Orlando | Florida | 32819 | United States |
| Research Site | Orlando | Florida | 32825 | United States |
| Research Site | Tampa | Florida | 33607 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Albany | Georgia | 31707 | United States |
| Research Site | Gainesville | Georgia | 30501 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Gurnee | Illinois | 60031 | United States |
| Research Site | Normal | Illinois | 61761 | United States |
| Research Site | Iowa City | Iowa | 52242 | United States |
| Research Site | Fort Mitchell | Kentucky | 41017 | United States |
| Research Site | Louisville | Kentucky | 40215 | United States |
| Research Site | Covington | Louisiana | 70433 | United States |
| Research Site | Bangor | Maine | 04401 | United States |
| Research Site | Baltimore | Maryland | 21236 | United States |
| Research Site | Quincy | Massachusetts | 02169 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Farmington Hills | Michigan | 48336 | United States |
| Research Site | Flint | Michigan | 48504 | United States |
| Research Site | Traverse City | Michigan | 49684 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | Saint Paul | Minnesota | 55130 | United States |
| Research Site | St Louis | Missouri | 63143 | United States |
| Research Site | Northfield | New Jersey | 08225 | United States |
| Research Site | Union | New Jersey | 07083 | United States |
| Research Site | Albuquerque | New Mexico | 87131 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Staten Island | New York | 10305 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | Durham | North Carolina | 27705 | United States |
| Research Site | Wilmington | North Carolina | 28401 | United States |
| Research Site | Winston-Salem | North Carolina | 27104 | United States |
| Research Site | Cincinnati | Ohio | 45231 | United States |
| Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Research Site | Oklahoma City | Oklahoma | 73103 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | Oklahoma City | Oklahoma | 73131 | United States |
| Research Site | Tulsa | Oklahoma | 74136 | United States |
| Research Site | Jefferson Hills | Pennsylvania | 15025 | United States |
| Research Site | Philadelphia | Pennsylvania | 19140 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Site | Warwick | Rhode Island | 02886 | United States |
| Research Site | Hodges | South Carolina | 29653 | United States |
| Research Site | Rapid City | South Dakota | 57702 | United States |
| Research Site | Arlington | Texas | 76018 | United States |
| Research Site | Boerne | Texas | 78006 | United States |
| Research Site | Dallas | Texas | 75225 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Dallas | Texas | 75235 | United States |
| Research Site | Houston | Texas | 77058 | United States |
| Research Site | Houston | Texas | 77081 | United States |
| Research Site | Houston | Texas | 77083 | United States |
| Research Site | Houston | Texas | 77099 | United States |
| Research Site | McAllen | Texas | 78504 | United States |
| Research Site | McKinney | Texas | 75069 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Splendora | Texas | 77372 | United States |
| Research Site | Provo | Utah | 84604 | United States |
| Research Site | Salt Lake City | Utah | 84112 | United States |
| Research Site | Abingdon | Virginia | 24210 | United States |
| Research Site | Falls Church | Virginia | 22044 | United States |
| Research Site | Greenfield | Wisconsin | 53228 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | Buenos Aires | 1121 | Argentina |
| Research Site | Buenos Aires | C1414AIF | Argentina |
| Research Site | CABA | C1056ABJ | Argentina |
| Research Site | CABA | C1425BEN | Argentina |
| Research Site | CABA | C1431FWO | Argentina |
| Research Site | Ciudad Autónoma de Bs. As. | 1426 | Argentina |
| Research Site | Concepción del Uruguay | 3260 | Argentina |
| Research Site | Corrientes | 3400 | Argentina |
| Research Site | Córdoba | X5003DCE | Argentina |
| Research Site | Florida | 1138 | Argentina |
| Research Site | Godoy Cruz | Argentina |
| Research Site | La Plata | B1902COS | Argentina |
| Research Site | Mar del Plata | B7600GNY | Argentina |
| Research Site | Mendoza | 5500 | Argentina |
| Research Site | Mendoza | M5500GIP | Argentina |
| Research Site | Nueve de Julio | B6500EZL | Argentina |
| Research Site | Ranelagh | 1886 | Argentina |
| Research Site | Rosario | S2000DEJ | Argentina |
| Research Site | San Miguel de Tucumán | 4000 | Argentina |
| Research Site | Bedford Park | 5042 | Australia |
| Research Site | Box Hill | 3128 | Australia |
| Research Site | Clayton | 3168 | Australia |
| Research Site | Concord | 2139 | Australia |
| Research Site | Frankston | 3199 | Australia |
| Research Site | Nedlands | 6009 | Australia |
| Research Site | New Lambton Heights | 2305 | Australia |
| Research Site | Parkville | 3050 | Australia |
| Research Site | Prahran | 3004 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | Woolloongabba | 4102 | Australia |
| Research Site | Porto Alegre | 90035074 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Santo André | 09080-110 | Brazil |
| Research Site | São Paulo | 04323-062 | Brazil |
| Research Site | São Paulo | 05403-000 | Brazil |
| Research Site | Sorocaba | 18040-425 | Brazil |
| Research Site | Dupnitsa | 2600 | Bulgaria |
| Research Site | Pazardzhik | 4400 | Bulgaria |
| Research Site | Pernik | 2300 | Bulgaria |
| Research Site | Petrich | 2850 | Bulgaria |
| Research Site | Pleven | 5800 | Bulgaria |
| Research Site | Rousse | 7002 | Bulgaria |
| Research Site | Samokov | 2000 | Bulgaria |
| Research Site | Sliven | 8800 | Bulgaria |
| Research Site | Sofia | 1002 | Bulgaria |
| Research Site | Sofia | 1152 | Bulgaria |
| Research Site | Stara Zagora | 6003 | Bulgaria |
| Research Site | Varna | 9000 | Bulgaria |
| Research Site | Velingrad | 4600 | Bulgaria |
| Research Site | Vratsa | 3000 | Bulgaria |
| Research Site | Yambol | 8600 | Bulgaria |
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Research Site | Sherwood Park | Alberta | T8L 0N2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Research Site | Burlington | Ontario | L7N 3V2 | Canada |
| Research Site | Hamilton | Ontario | L8N 4A6 | Canada |
| Research Site | Ottawa | Ontario | K1G 6C6 | Canada |
| Research Site | Montreal | Quebec | H2W 1T8 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Québec | Quebec | G1G 3Y8 | Canada |
| Research Site | Québec | Quebec | G1V 4G5 | Canada |
| Research Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| Research Site | Quillota | 2260000 | Chile |
| Research Site | Santiago | 8207257 | Chile |
| Research Site | Talcahuano | 4270918 | Chile |
| Research Site | Valparaíso | 2341131 | Chile |
| Research Site | Viña del Mar | 2520594 | Chile |
| Research Site | Jindřichův Hradec | 377 01 | Czechia |
| Research Site | Karlovy Vary | 360 17 | Czechia |
| Research Site | Ostrava | 728 80 | Czechia |
| Research Site | Pilsen | 30460 | Czechia |
| Research Site | Prague | 130 00 | Czechia |
| Research Site | Rokycany | 337 22 | Czechia |
| Research Site | Strakonice | 38601 | Czechia |
| Research Site | Teplice | 415 01 | Czechia |
| Research Site | Brest | 29609 | France |
| Research Site | Dijon | 21079 | France |
| Research Site | Le Kremlin-Bicêtre | 94275 | France |
| Research Site | Le Mans | 72037 | France |
| Research Site | Lyon | 69317 | France |
| Research Site | Marseille | 13015 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Paris | 75018 | France |
| Research Site | Pau | 64046 | France |
| Research Site | Pringy | 74374 | France |
| Research Site | Saint-Pierre | 97448 | France |
| Research Site | Strasbourg | 67091 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Aschaffenburg | 63739 | Germany |
| Research Site | Bamberg | 96049 | Germany |
| Research Site | Berlin | 10367 | Germany |
| Research Site | Berlin | 10717 | Germany |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Berlin | 12203 | Germany |
| Research Site | Bonn | 53123 | Germany |
| Research Site | Frankfurt | 60596 | Germany |
| Research Site | Frankfurt am Main | 60389 | Germany |
| Research Site | Frankfurt am Main | 60596 | Germany |
| Research Site | Geesthacht | 21502 | Germany |
| Research Site | Großhansdorf | 22927 | Germany |
| Research Site | Hamburg | 22299 | Germany |
| Research Site | Hanover | 30167 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Hanover | D-30173 | Germany |
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| Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8. |
| Related Info | View source |
| BORA clinical study protocol-redacted | View source |
| FG002 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| FG003 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| Treated |
|
| Adolescents Only |
|
| COMPLETED | Include patients enrolled into study MELTEMI (study 37) |
|
| NOT COMPLETED |
|
|
Full analysis population defined as treated for at least 1 treatment, excluding patients enrolled in MELTEMI.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| BG001 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| BG002 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| BG003 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| BG004 | 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 | Full analysis set, excluding MELTEMI patients | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Full analysis set, exclude MELTEMI patients | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Full analysis set | Number | Participants |
|
| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Basophils. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 56 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Basophils. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Leukocytes. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Leukocytes. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Lymphocytes. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Lymphocytes. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Neutrophils. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Neutrophils. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in hematologic lab parameter of Eosinophils. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Eosinophils. | Full analysis set, adolescents only(studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | 10^9 cells/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry tests ALT. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | ukat/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of ALT. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | ukat/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry tests AST. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | ukat/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of AST. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | ukat/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients | Change from baseline in chemistry test Bilirubin. | Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | umol/L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) | Change from baseline in hematologic lab parameter of Bilirubin. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value. | Posted | Mean | Standard Deviation | umol/L | Week 108 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Overall Patients With Asthma Exacerbations During Study Period | Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit | Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups. | Posted | Count of Participants | Participants | From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) | Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Count of Participants | Participants | From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pre-bronchodilator FEV1 (L) | Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1). | Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1). | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | L | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Post-bronchodilator FEV1 (L) | Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1). | Full analysis set, excluding MELTEMI patients. Only summarize for patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; separated by predecessor treatment groups. Patients from Study ZONDA are not summarized. | Posted | Mean | Standard Deviation | L | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) | Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1). | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | L | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients | Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses. | Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Score on a scale | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) | Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Score on a scale | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) | Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement. | Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA. | Posted | Mean | Standard Deviation | Score on a scale | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) | Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Score on a scale | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of Blood Eosinophil Levels' Measurement in Overall Patients | Change from baseline to Week 56 in Blood eosinophils | Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separate by predecessor treatment groups. | Posted | Mean | Standard Deviation | cell/uL | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). | Change from baseline to Week 108 in Blood eosinophils. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | cell/uL | Week 108 |
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| Secondary | Change From Baseline in EQ-5D-5L Visual Analog Scale | The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement. | Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA. | Posted | Mean | Standard Deviation | Score on a scale | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) | The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Score on a scale | Week 108 |
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| Secondary | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage. | Full analysis set, adults, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA. | Posted | Mean | Standard Deviation | percentage | Week 68 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Percentage | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) | The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage. | Full analysis set, adolescents, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA. | Posted | Mean | Standard Deviation | Percentage | Week 56 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) | The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Percentage | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA. | Posted | Mean | Standard Deviation | percentage | Week 68 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) | The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Mean | Standard Deviation | Percentage | Week 108 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period | Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma | Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA. | Posted | Count of Participants | Participants | From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) | Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups. | Posted | Count of Participants | Participants | Baseline and Week 108 |
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| Secondary | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study | Endpoint: Pharmacokinetic (PK) parameters | All patients who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Week 0 and Week 56 |
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| Secondary | Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) | Endpoint: Pharmacokinetic (PK) parameters | All adolescent patients (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents)who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Baseline and Week 108 |
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| Secondary | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study | Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study | Full analysis set, excluding MELTEMI patients. | Posted | Number | Participants | From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period |
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| Secondary | Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) | Assessments for the presence of ADA and nAb throughout study | Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). | Posted | Number | Participants | From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period |
|
|
Adults completed 56 weeks of treatment period and 12 weeks follow-up period; and adolescents completed 108 weeks of treatment period and 12 weeks follow-up period.
Not provided
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 | SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 Weeks | 5 | 783 | 102 | 783 | 415 | 783 |
| EG001 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 Weeks | 4 | 793 | 94 | 793 | 409 | 793 |
| EG002 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 Weeks | 0 | 49 | 10 | 49 | 33 | 49 |
| EG003 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 Weeks | 1 | 49 | 9 | 49 | 38 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Solid pseudopapillary tumour of the pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Femoral hernia strangulated | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Endocrine test abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Benign neoplasm of eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Large intestine benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Osteochondroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lumbosacral radiculopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vaginal fistula | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Middle lobe syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Patients in this study had to complete treatment in predecessor studies. Therefore selection bias may exist. Baseline is defined for this study's entry value, not all values are prior to active treatment due to some patients being treated previously.
≥ 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 | |
|---|---|---|---|---|
| Ubaldo Martin, Global Clinical Lead Benralizumab | AstraZeneca | +1 301 398 0163 | Ubaldo.Martin@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2017 | Oct 15, 2018 | SAP_001.pdf |
| 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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| Black and African American |
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| Asian |
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| Other |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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|
|
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| OG006 | ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment |
| OG007 | ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment |
| OG008 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG009 | ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG010 | ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG011 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 4 weeks
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| OG006 | ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment |
| OG007 | ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment |
| OG008 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG009 | ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG010 | ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG011 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG003 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 |
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| OG006 | ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment |
| OG007 | ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment |
| OG008 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG009 | ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG010 | ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG011 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| OG006 | ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment |
| OG007 | ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment |
| OG008 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG009 | ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG010 | ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG011 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 4 weeks |
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| OG006 | ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4 | Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment |
| OG007 | ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo | Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment |
| OG008 | ZONDA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG009 | ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG010 | ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG011 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
|
|
| OG003 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 |
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 4 weeks |
| OG003 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG002 | SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 4 weeks |
| OG003 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG002 | SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG003 | ZONDA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
| SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks |
Benralizumab administered subcutaneously every 4 weeks |
| OG003 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks |
|
|
| OG003 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8 |
Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG004 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG005 | SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
|
|
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
| OG004 | ZONDA - Benra 30 mg q.4 Weeks - Pre Benra q.4 | Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment |
| OG005 | ZONDA - Benra 30 mg q.4 wk - Predecessor Placebo | Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment |
| OG006 | ZONDA - Benra 30 mg q.8 Weeks - Pre Benra q.8 | Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment |
| OG007 | ZONDA - Benra 30 mg q.8 wk - Predecessor Placebo | Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
|
|
| OG003 |
| SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo |
Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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